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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97846

20 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 30, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medline Industries, LP

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

20 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 20

MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M

Z-0511-2026
Recall number
Z-0511-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
48 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

UDI/DI 10195327384371 (each), 40195327384372 (case), Lot Numbers: 24CBO120, 24DBA216

Distribution pattern

US Nationwide distribution.

device · product 2 of 20

MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A

Z-0512-2026
Recall number
Z-0512-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
12 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

UDI/DI 10195327333256 (each), 40195327333257 (case), Lot Numbers: 23KLA460

Distribution pattern

US Nationwide distribution.

device · product 3 of 20

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.

Z-0513-2026
Recall number
Z-0513-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
5133 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) CDS840261AB: UDI/DI 10195327104535 (each), 40195327104536 (case), Lot Numbers: 23FBF165, 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each), 40195327228126 (case), Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each), 40195327327829 (case), Lot Numbers: 23FBA013, 23FBH486, 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Numbers: 23GBT133, 23HBH924, 23HBL135, 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each), 40193489288606 (case), Lot Numbers: 23KBU348, 24ABB883, 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each), 40195327357284 (case), Lot Numbers: 23GDB197, 23GDB757. 7) DYNJ0421380P: UDI/DI 10195327084271 (each), 40195327084272 (case), Lot Numbers: 23DMI590, 23FMJ656. 8) DYNJ21877W: UDI/DI 10195327104542 (each), 40195327104543 (case), Lot Numbers: 23FBT682, 23GBF898, 23IBC645, 24ABR316. 9) DYNJ22350L: UDI/DI 10193489445251 (each), 40193489445252 (case), Lot Numbers: 23LBU055, 24BBQ300. 10) DYNJ27432AC: UDI/DI 10195327104511 (each), 40195327104512 (case), Lot Numbers: 23EBU150, 23GBF873, 23HBQ650, 23IBB637. 11) DYNJ37284K: UDI/DI 10195327401030 (each), 40195327401031 (case), Lot Numbers: 23IBP124, 23KBF938, 24ABS487. 12) DYNJ38175L: UDI/DI 10195327227906 (each), 40195327227907 (case), Lot Numbers: 23FLA915, 23ILA168. 13) DYNJ42921G: UDI/DI 10193489981384 (each), 40193489981385 (case), Lot Numbers: 23FBU282, 23IBT172. 14) DYNJ43207K: UDI/DI 10193489952926 (each), 40193489952927 (case), Lot Numbers: 23EME962. 15) DYNJ43214F: UDI/DI 10193489953077 (each), 40193489953078 (case), Lot Numbers: 23EMA158. 16) DYNJ44847I: UDI/DI 10195327127558 (each), 40195327127559 (case), Lot Numbers: 23HLA758, 23HLB101, 23LLA759. 17) DYNJ44857U: UDI/DI 10195327298067 (each), 40195327298068 (case), Lot Numbers: 23GBI967, 23GBQ950. 18) DYNJ44869K: UDI/DI 10195327127657 (each), 40195327127658 (case), Lot Numbers: 23GBI967, 23GBQ950, 23KMC104. 19) DYNJ44879K: UDI/DI 10195327282233 (each), 40195327282234 (case), Lot Numbers: 23DBI854, 23EBH319, 23GBT541. 20) DYNJ44886M: UDI/DI 10195327127749 (each), 40195327127740 (case), Lot Numbers: 23DBN895, 23EBU129, 23FBQ134, 23GBQ953, 23HBT951. 21) DYNJ50528M: UDI/DI 10195327129699 (each), 40195327129690 (case), Lot Numbers: 23EBA780, 23EBS770, 23GBT274. 22) DYNJ51038R: UDI/DI 10195327298258 (each), 40195327298259 (case), Lot Numbers: 23HBD834. 23) DYNJ56838F: UDI/DI 10195327277857 (each), 40195327277858 (case), Lot Numbers: 23GDA228, 23HDA839. 24) DYNJ56839D: UDI/DI 10195327277864 (each), 40195327277865 (case), Lot Numbers: 23GDA320. 25) DYNJ60548B: UDI/DI 10195327361761 (each), 40195327361762 (case), Lot Numbers: 23EBD777, 23IBS545, 23JBJ740. 26) DYNJ60783B: UDI/DI 10195327361846 (each), 40195327361847 (case), Lot Numbers : 23EBR616, 23GBW384, 23IBV398. 27) DYNJ61659A: UDI/DI 10193489929638 (each), 40193489929639 (case), Lot Numbers: 23HBI627. 28) DYNJ62097C: UDI/DI 10195327189839 (each), 40195327189830 (case), Lot Numbers: 23DBJ117, 23EBD473, 23HBQ663, 23IBB641. 29) DYNJ65039C: UDI/DI 10195327528256 (each), 40195327528257 (case), Lot Numbers: 24BMF955, 24CMB409, 24CME382, 24FMH176. 30) DYNJ66033B: UDI/DI 10195327680589 (each), 40195327680580 (case), Lot Numbers: 24EBA176. 31) DYNJ80609D: UDI/DI 10195327298296 (each), 40195327298297 (case), Lot Numbers: 23HBR318, 23HBZ183. 32) DYNJ81581B: UDI/DI 10195327379254 (each), 40195327379255 (case), Lot Numbers: 23EBO537, 23GBQ499, 23HBG425. 33) DYNJ81605: UDI/DI 10195327123888 (each), 40195327123889 (case), Lot Numbers: 23DBL829, 23EBI374, 23EBM656. 34) DYNJ81610B: UDI/DI 10195327398316 (each), 40195327398317 (case), Lot Numbers: 23EBA748, 23IBP506. 35) DYNJ82166: UDI/DI 10195327182564 (each), 40195327182565 (case), Lot Numbers: 23FDA955. 36) DYNJ82217: UDI/DI 10195327183585 (each), 40195327183586 (case), Lot Numbers: 23DDB931, 23HDA667. 37) DYNJ84017B: UDI/DI 10198459253089 (each), 40198459253080 (case), Lot Numbers: 25CMF132. 38) DYNJ85109: UDI/DI 10195327460594 (each), 40195327460595 (case), Lot Numbers: 23JBD986. 39) DYNJ85110: UDI/DI 10195327460792 (each), 40195327460793 (case), Lot Numbers: 23KBF140. 40) DYNJ85118: UDI/DI 10195327460730 (each), 40195327460731 (case), Lot Numbers: 23KBI277. 41) DYNJ85121: UDI/DI 10195327460853 (each), 40195327460854 (case), Lot Numbers: 23IBR236, 23JBC564. 42) DYNJ85637: UDI/DI 10195327528188 (each), 40195327528189 (case), Lot Numbers: 24CBL150. 43) DYNJ900293K: UDI/DI 10195327554064 (each), 40195327554065 (case), Lot Numbers: 24ABE610, 24BBT270, 24DBU219. 44) DYNJ900714C: UDI/DI 10193489951363 (each), 40193489951364 (case), Lot Numbers: 23FBL767, 23HBW562, 23JBF697. 45) DYNJ901066K: UDI/DI 10195327239282 (each), 40195327239283 (case), Lot Numbers: 23HBB464, 23HBC020, 23JBF553, 23JBW634. 46) DYNJ903042P: UDI/DI 10195327438388 (each), 40195327438389 (case), Lot Numbers: 23JBL424, 23LBL094, 24ABS138. 47) DYNJ905079F: UDI/DI 10195327209001 (each), 40195327209002 (case), Lot Numbers: 23GBV464, 23HBO354. 48) DYNJ905497B: UDI/DI 10193489951639 (each), 40193489951630 (case), Lot Numbers: 23GBB505, 23HBN192, 23JBV542, 23JBV684. 49) DYNJ906175B: UDI/DI 10195327480127 (each), 40195327480128 (case), Lot Numbers: 24FMI570. 50) DYNJ907105D: UDI/DI 10195327233624 (each), 40195327233625 (case), Lot Numbers: 23EBG144, 23EBT013, 23FBI805, 23FBQ992. 51) DYNJ907904A: UDI/DI 10193489992434 (each), 40193489992435 (case), Lot Numbers: 23JME513, 23KMD522. 52) DYNJ908820: UDI/DI 10195327185671 (each), 40195327185672 (case), Lot Numbers: 23JMG465, 23KMI460. 53) DYNJ908820A: UDI/DI 10195327546045 (each), 40195327546046 (case), Lot Numbers: 23LMH559, 24CMA145, 24DMF994, 24DMI666.

Distribution pattern

US Nationwide distribution.

device · product 4 of 20

MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.

Z-0514-2026
Recall number
Z-0514-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
142 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF DYNJ00281P: UDI/DI 10195327411954 (each), 40195327411955 (case), Lot Numbers: 23GMD333, 23HMC426; 2) REF DYNJ68213C: UDI/DI 10195327511999 (each), 40195327511990 (case), Lot Numbers: 23IMI021, 23KMJ671.

Distribution pattern

US Nationwide distribution.

device · product 5 of 20

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.

Z-0515-2026
Recall number
Z-0515-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
301 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF DYNJ0160598C: UDI/DI 10195327304270 (each), 40195327304271 (case), Lot Numbers: 23DDC250, 23GDA351; 2) REF DYNJ65361A: UDI/DI 10195327415051 (each), 40195327415052 (case), Lot Numbers: 24BMC296; 3) REF DYNJ908839A: UDI/DI 10195327431822 (each), 40195327431823 (case), Lot Numbers: 23GBL904, 23GBU981, 23HBF736, 23HBO368, 24BBP268, 24CBO698, 24EBS782.

Distribution pattern

US Nationwide distribution.

device · product 6 of 20

MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF DYNJ64235B; 12) NECK PACK SRM-LF, REF DYNJ65020C; 13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 14) ENT HEAD NECK PACK, REF DYNJ68211B; 15) OSC ENT HEAD PACK, REF DYNJ68957B; 16) EAR UM-LF, REF DYNJ902331D; 17) HEAD&NECK, REF DYNJ906655G; 18) ENT-LF, REF DYNJ907577; 19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q; 20) MINOR ENT # 56653-LF, REF DYNJVB91072A.

Z-0516-2026
Recall number
Z-0516-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
3078 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF CDS984259O: UDI/DI 10195327297817 (each), 40195327297818 (case), Lot Numbers: 23FBR754, 23GBH766, 24ABP608, 24BBN514; 2) REF CDS984259P: UDI/DI 10195327647827 (each), 40195327647828 (case), Lot Numbers: 24DBQ755; 3) REF DYNJ0160700F: UDI/DI 10195327304294 (each), 40195327304295 (case), Lot Numbers: 23FDA156, 23GDA649; 4) REF DYNJ0161710I: UDI/DI 10195327375003 (each), 40195327375004 (case), Lot Numbers: 23EDB639, 23FDA196, 23GDA674; 5) REF DYNJ0161795F: UDI/DI 10195327375010 (each), 40195327375011 (case), Lot Numbers: 23FDA246, 23HDA365; 6) REF DYNJ0429404O: UDI/DI 10195327050092 (each), 40195327050093 (case), Lot Numbers: 23GMI073, 23JMC414, 23LMA073; 7) REF DYNJ0429404P: UDI/DI 10195327587581 (each), 40195327587582 (case), Lot Numbers: 23LMH745, 24BME178, 24DMF230; 8) REF DYNJ0429430S: UDI/DI 10195327689841 (each), 40195327689842 (case), Lot Numbers: 24LME516; 9) REF DYNJ27320V: UDI/DI 10195327104719 (each), 40195327104710 (case), Lot Numbers: 23GBT502, 24ABD023, 24ABX584, 24DBA020, 24DBU467, 24FBD739; 10) REF DYNJ55235C: UDI/DI 10195327412081 (each), 40195327412082 (case), Lot Numbers: 23GBN444, 23IBU467; 11) REF DYNJ64235B: UDI/DI 10193489382662 (each), 40193489382663 (case), Lot Numbers: 23FMB928; 12) REF DYNJ65020C: UDI/DI 10195327528218 (each), 40195327528219 (case), Lot Numbers: 23JMD840, 23LME135, 24FMH184; 13) REF DYNJ67754B: UDI/DI 10195327227982 (each), 40195327227983 (case), Lot Numbers: 23EBK256, 23HBM886, 23IBP461, 23JBR528; 14) REF DYNJ68211B: UDI/DI 10195327352493 (each), 40195327352494 (case), Lot Numbers: 23HMC691; 15) REF DYNJ68957B: UDI/DI 10195327512033 (each), 40195327512034 (case), Lot Numbers: 23JMD230, 24AMB618; 16) REF DYNJ902331D: UDI/DI 10195327698089 (each), 40195327698080 (case), Lot Numbers: 24EBC946, 24EBV522; 17) REF DYNJ906655G: UDI/DI 10195327301835 (each), 40195327301836 (case), Lot Numbers: 24ADB523; 18) REF DYNJ907577: UDI/DI 10193489437713 (each), 40193489437714 (case), Lot Numbers: 23GBB195, 23GBN735; 19) REF DYNJ9425991Q: UDI/DI 10195327587604 (each), 40195327587605 (case), Lot Numbers: 24ALB133; 20) REF DYNJVB91072A: UDI/DI 10195327466428 (each), 40195327466429 (case), Lot Numbers: 23HLB079, 23ILA192, 24ALA650.

Distribution pattern

US Nationwide distribution.

device · product 7 of 20

MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF CDS860194I; 7) BASIC LAPAROSCOPY CDS, REF CDS920080T; 8) GENERAL LAPAROSCOPY, REF CDS930027V; 9) GENERAL LAPAROSCOPY, REF CDS930027X; 10) GENERAL MINOR CDS, REF CDS980246V; 11) BASIC CDS, REF CDS982936V; 12) MAJOR ABDOMINAL CDS, REF CDS983759L; 13) GENERAL SURGERY CDS, REF CDS983914L; 14) GENERAL LAP, REF CDS984251N; 15) ACH MINOR PROCEDURE, REF CDS985451G; 16) SCOPE LAP THOR PACK, REF DYNJ00210N; 17) MAJOR LAPAROTOMY PACK, REF DYNJ00387P; 18) MAJOR ABDOMINAL HARPER PACK-LF, REF DYNJ0160657D; 19) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 20) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 21) MAJOR PACK-LF, REF DYNJ0386381L; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 23) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 24) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 25) MAJOR LAPAROTOMY PACK, REF DYNJ20819M; 26) MAJOR ABDOMINAL, REF DYNJ23429G; 27) MINI LAPAROTOMY #16-RF, REF DYNJ27322S; 28) MINI LAPAROTOMY #16-RF, REF DYNJ27322T; 29) TN LAPAROTOMY PACK-LF, REF DYNJ34206I; 30) LAPAROTOMY, REF DYNJ34424N; 31) COREWELL TSC- LAP PACK-LF, REF DYNJ37100I; 32) GENERAL LAP PACK, REF DYNJ38223C; 33) LAP CHOLE PACK, REF DYNJ38228C; 34) MINOR PACK, REF DYNJ41418I; 35) GENERAL PACK-LF, REF DYNJ43213J; 36) HERNIA PACK, REF DYNJ44683L; 37) GENERAL ABDOMINAL, REF DYNJ44870J; 38) LAP CHOLE PACK, REF DYNJ44873I; 39) LAP RENAL PACK, REF DYNJ44875O; 40) MAJOR LAPAROTOMY, REF DYNJ45334G; 41) MAJOR LAPAROTOMY, REF DYNJ45334J; 42) MINOR PROCEDURE, REF DYNJ45336J; 43) MINOR PROCEDURE PACK, REF DYNJ47057D; 44) MINOR PROCEDURE PACK, REF DYNJ47057F; 45) MAJOR BASIC PACK (MBGSE)227-LF, REF DYNJ47696J; 46) LAP CHOLE PACK, REF DYNJ48092G; 47) LAPAROTOMY PACK, REF DYNJ48093F; 48) ISS GENERAL PACK, REF DYNJ48921I; 49) MINOR UROLOGY PACK, REF DYNJ49310F; 50) HERNIA SGM PACK-LF, REF DYNJ51434B; 51) MINOR GENERAL PACK, REF DYNJ52329C; 52) MINOR GENERAL PACK, REF DYNJ52329D; 53) MINOR GENERAL PACK, REF DYNJ52329F; 54) MINOR LAPAROTOMY PACK-LF, REF DYNJ52863D; 55) MINOR GENERAL PACK, REF DYNJ53036G; 56) MINOR GENERAL PACK, REF DYNJ53036I; 57) IPP PENILE PROSTHESIS PACK, REF DYNJ58061J; 58) MAJOR LAPAROTOMY PACK, REF DYNJ58561D; 59) MAJOR LAPAROTOMY PACK, REF DYNJ58561F; 60) MINOR PACK, REF DYNJ58562D; 61) MINOR PACK, REF DYNJ58562F; 62) MINOR GENERAL PACK, REF DYNJ59358D; 63) PACK HERNIA INGUINAL, REF DYNJ60145B; 64) PK CUST MAJOR ST MICHAEL, REF DYNJ60782B; 65) CENTRACARE PLAZA-LAP CHOLE PK, REF DYNJ61620C; 66) MINOR GEN PACK, REF DYNJ61661A; 67) SLCH MAJOR GENERAL PACK, REF DYNJ61666A; 68) DAVINCI PROSTATE PACK, REF DYNJ61711B; 69) THORACIC PACK, REF DYNJ62015C; etc

Z-0517-2026
Recall number
Z-0517-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
28679 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860016R: UDI/DI 10195327349479 (each) 40195327349470, (case), Lot Numbers: CDS860016R; REF CDS860016S: UDI/DI 10195327647520 (each) 40195327647521, (case), Lot Numbers: CDS860016S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V; REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V; REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V; REF CDS930027X: UDI/DI 10195327647698 (each) 40195327647699, (case), Lot Numbers: CDS930027X; REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V; REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V; REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V; REF CDS982936V: UDI/DI 10195327627324 (each) 40195327627325, (case), Lot Numbers: CDS982936V; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L; REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L; REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L; REF CDS984251N: UDI/DI 10193489862218 (each) 40193489862219, (case), Lot Numbers: CDS984251N; REF CDS984251N: UDI/DI 10193489862218 (each) 40193489862219, (case), Lot Numbers: CDS984251N; REF CDS985451G: UDI/DI 10195327237639 (each) 40195327237630, (case), Lot Numbers: CDS985451G; REF DYNJ00210N: UDI/DI 10195327412012 (each) 40195327412013, (case), Lot Numbers: DYNJ00210N; REF DYNJ00210N: UDI/DI 10195327412012 (each) 40195327412013, (case), Lot Numbers: DYNJ00210N; REF DYNJ00387P: UDI/DI 10195327412043 (each) 40195327412044, (case), Lot Numbers: DYNJ00387P; REF DYNJ00387P: UDI/DI 10195327412043 (each) 40195327412044, (case), Lot Numbers: DYNJ00387P; REF DYNJ0160657D: UDI/DI 10195327404543 (each) 40195327404544, (case), Lot Numbers: DYNJ0160657D; REF DYNJ0161299C: UDI/DI 10195327357276 (each) 40195327357277, (case), Lot Numbers: DYNJ0161299C; REF DYNJ0311538N: UDI/DI 10889942826612 (each) 40889942826613, (case), Lot Numbers: DYNJ0311538N; REF DYNJ0311538N: UDI/DI 10889942826612 (each) 40889942826613, (case), Lot Numbers: DYNJ0311538N; REF DYNJ0311538N: UDI/DI 10889942826612 (each) 40889942826613, (case), Lot Numbers: DYNJ0311538N; REF DYNJ0386381L: UDI/DI 10195327219048 (each) 40195327219049, (case), Lot Numbers: DYNJ0386381L; REF DYNJ0386381L: UDI/DI 10195327219048 (each) 40195327219049, (case), Lot Numbers: DYNJ0386381L; REF DYNJ0386381L: UDI/DI 10195327219048 (each) 40195327219049, (case), Lot Numbers: DYNJ0386381L; REF DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310, (case), Lot Numbers: DYNJ0426069N; REF DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310, (case), Lot Numbers: DYNJ0426069N; REF DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310, (case), Lot Numbers: DYNJ0426069N; REF DYNJ0519288N: UDI/DI 10195327083960 (each) 40195327083961, (case), Lot Numbers: DYNJ0519288N; REF DYNJ0519288N: UDI/DI 10195327083960 (each) 40195327083961, (case), Lot Numbers: DYNJ0519288N; REF DYNJ0751401S: UDI/DI 10195327334185 (each) 40195327334186, (case), Lot Numbers: DYNJ0751401S; REF DYNJ0751401S: UDI/DI 10195327334185 (each) 40195327334186, (case), Lot Numbers: DYNJ0751401S; REF DYNJ20819M: UDI/DI 10195327191450 (each) 40195327191451, (case), Lot Numbers: DYNJ20819M; REF DYNJ20819M: UDI/DI 10195327191450 (each) 40195327191451, (case), Lot Numbers: DYNJ20819M; REF DYNJ23429G: UDI/DI 10195327528768 (each) 40195327528769, (case), Lot Numbers: DYNJ23429G; REF DYNJ27322S: UDI/DI 10195327140649 (each) 40195327140640, (case), Lot Numbers: DYNJ27322S; REF DYNJ27322T: UDI/DI 10195327580452 (each) 40195327580453, (case), Lot Numbers: DYNJ27322T; REF DYNJ27322T: UDI/DI 10195327580452 (each) 40195327580453, (case), Lot Numbers: DYNJ27322T; REF DYNJ27322T: UDI/DI 10195327580452 (each) 40195327580453, (case), Lot Numbers: DYNJ27322T; REF DYNJ34206I: UDI/DI 10195327449124 (each) 40195327449125, (case), Lot Numbers: DYNJ34206I; REF DYNJ34424N: UDI/DI 10195327610623 (each) 40195327610624, (case), Lot Numbers: DYNJ34424N; REF DYNJ34424N: UDI/DI 10195327610623 (each) 40195327610624, (case), Lot Numbers: DYNJ34424N; REF DYNJ37100I: UDI/DI 10195327449148 (each) 40195327449149, (case), Lot Numbers: DYNJ37100I; REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C; REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C; REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C; REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C; REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C; REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C; REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I; REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I; REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I; REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I; REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I; REF DYNJ43213J: UDI/DI 10193489953060 (each) 40193489953061, (case), Lot Numbers: DYNJ43213J; REF DYNJ43213J: UDI/DI 10193489953060 (each) 40193489953061, (case), Lot Numbers: DYNJ43213J; REF DYNJ44683L: UDI/DI 10195327127398 (each) 40195327127399, (case), Lot Numbers: DYNJ44683L; REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J; REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J; REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J; REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J; REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J; REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I; REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I; REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I; REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I; REF DYNJ44875O: UDI/DI 10195327127688 (each) 40195327127689, (case), Lot Numbers: DYNJ44875O; REF DYNJ45334G: UDI/DI 10195327242541 (each) 40195327242542, (case), Lot Numbers: DYNJ45334G; REF DYNJ45334J: UDI/DI 10195327507640 (each) 40195327507641, (case), Lot Numbers: DYNJ45334J; REF DYNJ45336J: UDI/DI 10195327507480 (each) 40195327507481, (case), Lot Numbers: DYNJ45336J; REF DYNJ45336J: UDI/DI 10195327507480 (each) 40195327507481, (case), Lot Numbers: DYNJ45336J; REF DYNJ47057D: UDI/DI 10193489827569 (each) 40193489827560, (case), Lot Numbers: DYNJ47057D; REF DYNJ47057D: UDI/DI 10193489827569 (each) 40193489827560, (case), Lot Numbers: DYNJ47057D; REF DYNJ47057F: UDI/DI 10195327653415 (each) 40195327653416, (case), Lot Numbers: DYNJ47057F; REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J; REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J; REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J; REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J; REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J; REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J; REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J; REF DYNJ48092G: UDI/DI 10195327500146 (each) 40195327500147, (case), Lot Numbers: DYNJ48092G; REF DYNJ48092G: UDI/DI 10195327500146 (each) 40195327500147, (case), Lot Numbers: DYNJ48092G; REF DYNJ48092G: UDI/DI 10195327500146 (each) 40195327500147, (case), Lot Numbers: DYNJ48092G; REF DYNJ48093F: UDI/DI 10195327500153 (each) 40195327500154, (case), Lot Numbers: DYNJ48093F; REF DYNJ48093F: UDI/DI 10195327500153 (each) 40195327500154, (case), Lot Numbers: DYNJ48093F; REF DYNJ48093F: UDI/DI 10195327500153 (each) 40195327500154, (case), Lot Numbers: DYNJ48093F; REF DYNJ48921I: UDI/DI 10195327529826 (each) 40195327529827, (case), Lot Numbers: DYNJ48921I; REF DYNJ48921I: UDI/DI 10195327529826 (each) 40195327529827, (case), Lot Numbers: DYNJ48921I; REF DYNJ48921I: UDI/DI 10195327529826 (each) 40195327529827, (case), Lot Numbers: DYNJ48921I; REF DYNJ49310F: UDI/DI 10195327546373 (each) 40195327546374, (case), Lot Numbers: DYNJ49310F; REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B; REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B; REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B; REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B; REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B; REF DYNJ52329C: UDI/DI 10195327237677 (each) 40195327237678, (case), Lot Numbers: DYNJ52329C; REF DYNJ52329D: UDI/DI 10195327434069 (each) 40195327434060, (case), Lot Numbers: DYNJ52329D; REF DYNJ52329F: UDI/DI 10195327484057 (each) 40195327484058, (case), Lot Numbers: DYNJ52329F; REF DYNJ52329F: UDI/DI 10195327484057 (each) 40195327484058, (case), Lot Numbers: DYNJ52329F; REF DYNJ52863D: UDI/DI 10195327191481 (each) 40195327191482, (case), Lot Numbers: DYNJ52863D; REF DYNJ53036G: UDI/DI 10195327385842 (each) 40195327385843, (case), Lot Numbers: DYNJ53036G; REF DYNJ53036G: UDI/DI 10195327385842 (each) 40195327385843, (case), Lot Numbers: DYNJ53036G; REF DYNJ53036I: UDI/DI 10195327608354 (each) 40195327608355, (case), Lot Numbers: DYNJ53036I; REF DYNJ58061J: UDI/DI 10195327463595 (each) 40195327463596, (case), Lot Numbers: DYNJ58061J; REF DYNJ58061J: UDI/DI 10195327463595 (each) 40195327463596, (case), Lot Numbers: DYNJ58061J; REF DYNJ58561D: UDI/DI 10193489972306 (each) 40193489972307, (case), Lot Numbers: DYNJ58561D; REF DYNJ58561D: UDI/DI 10193489972306 (each) 40193489972307, (case), Lot Numbers: DYNJ58561D; REF DYNJ58561D: UDI/DI 10193489972306 (each) 40193489972307, (case), Lot Numbers: DYNJ58561D; REF DYNJ58561F: UDI/DI 10195327615215 (each) 40195327615216, (case), Lot Numbers: DYNJ58561F; REF DYNJ58561F: UDI/DI 10195327615215 (each) 40195327615216, (case), Lot Numbers: DYNJ58561F; REF DYNJ58561F: UDI/DI 10195327615215 (each) 40195327615216, (case), Lot Numbers: DYNJ58561F; REF DYNJ58562D: UDI/DI 10193489972313 (each) 40193489972314, (case), Lot Numbers: DYNJ58562D; REF DYNJ58562D: UDI/DI 10193489972313 (each) 40193489972314, (case), Lot Numbers: DYNJ58562D; REF DYNJ58562F: UDI/DI 10195327615222 (each) 40195327615223, (case), Lot Numbers: DYNJ58562F; REF DYNJ59358D: UDI/DI 10195327127824 (each) 40195327127825, (case), Lot Numbers: DYNJ59358D; REF DYNJ59358D: UDI/DI 10195327127824 (each) 40195327127825, (case), Lot Numbers: DYNJ59358D; REF DYNJ60145B: UDI/DI 10193489982848 (each) 40193489982849, (case), Lot Numbers: DYNJ60145B; REF DYNJ60782B: UDI/DI 10195327361839 (each) 40195327361830, (case), Lot Numbers: DYNJ60782B; REF DYNJ61620C: UDI/DI 10195327310011 (each) 40195327310012, (case), Lot Numbers: DYNJ61620C; REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A; REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A; REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A; REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A; REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A; REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A; REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A; REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A; REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A; REF DYNJ61711B: UDI/DI 10193489874723 (each) 40193489874724, (case), Lot Numbers: DYNJ61711B; REF DYNJ62015C: UDI/DI 10195327560676 (each) 40195327560677, (case), Lot Numbers: DYNJ62015C; REF DYNJ62015C: UDI/DI 10195327560676 (each) 40195327560677, (case), Lot Numbers: DYNJ62015C; REF DYNJ62397C: UDI/DI 10195327401023 (each) 40195327401024, (case), Lot Numbers: DYNJ62397C; REF DYNJ62611D: UDI/DI 10195327528164 (each) 40195327528165, (case), Lot Numbers: DYNJ62611D; REF DYNJ62611D: UDI/DI 10195327528164 (each) 40195327528165, (case), Lot Numbers: DYNJ62611D; REF DYNJ62611D: UDI/DI 10195327528164 (each) 40195327528165, (case), Lot Numbers: DYNJ62611D; REF DYNJ63084C: UDI/DI 10195327505639 (each) 40195327505630, (case), Lot Numbers: DYNJ63084C; REF DYNJ63084C: UDI/DI 10195327505639 (each) 40195327505630, (case), Lot Numbers: DYNJ63084C; REF DYNJ63084C: UDI/DI 10195327505639 (each) 40195327505630, (case), Lot Numbers: DYNJ63084C; REF DYNJ63285: UDI/DI 10193489733013 (each) 40193489733014, (case), Lot Numbers: DYNJ63285; REF DYNJ63285A: UDI/DI 10198459104183 (each) 40198459104184, (case), Lot Numbers: DYNJ63285A; REF DYNJ63405C: UDI/DI 10195327448431 (each) 40195327448432, (case), Lot Numbers: DYNJ63405C; REF DYNJ63498C: UDI/DI 10195327510954 (each) 40195327510955, (case), Lot Numbers: DYNJ63498C; REF DYNJ64238C: UDI/DI 10195327452322 (each) 40195327452323, (case), Lot Numbers: DYNJ64238C; REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A; REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A; REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A; REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A; REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A; REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A; REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A; REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A; REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A; REF DYNJ65362A: UDI/DI 10195327417772 (each) 40195327417773, (case), Lot Numbers: DYNJ65362A; REF DYNJ65371A: UDI/DI 10195327417963 (each) 40195327417964, (case), Lot Numbers: DYNJ65371A; REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B; REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B; REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B; REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B; REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B; REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B; REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B; REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B; REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B; REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B; REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B; REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B; REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B; REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B; REF DYNJ67540A: UDI/DI 10195327247591 (each) 40195327247592, (case), Lot Numbers: DYNJ67540A; REF DYNJ67540A: UDI/DI 10195327247591 (each) 40195327247592, (case), Lot Numbers: DYNJ67540A; REF DYNJ67540A: UDI/DI 10195327247591 (each) 40195327247592, (case), Lot Numbers: DYNJ67540A; REF DYNJ69858: UDI/DI 10193489987102 (each) 40193489987103, (case), Lot Numbers: DYNJ69858; REF DYNJ80171A: UDI/DI 10195327416775 (each) 40195327416776, (case), Lot Numbers: DYNJ80171A; REF DYNJ80171A: UDI/DI 10195327416775 (each) 40195327416776, (case), Lot Numbers: DYNJ80171A; REF DYNJ80171A: UDI/DI 10195327416775 (each) 40195327416776, (case), Lot Numbers: DYNJ80171A; REF DYNJ81599: UDI/DI 10195327124021 (each) 40195327124022, (case), Lot Numbers: DYNJ81599; REF DYNJ81599: UDI/DI 10195327124021 (each) 40195327124022, (case), Lot Numbers: DYNJ81599; REF DYNJ81599: UDI/DI 10195327124021 (each) 40195327124022, (case), Lot Numbers: DYNJ81599; REF DYNJ81602: UDI/DI 10195327123857 (each) 40195327123858, (case), Lot Numbers: DYNJ81602; REF DYNJ81602: UDI/DI 10195327123857 (each) 40195327123858, (case), Lot Numbers: DYNJ81602; REF DYNJ81602: UDI/DI 10195327123857 (each) 40195327123858, (case), Lot Numbers: DYNJ81602; REF DYNJ81603: UDI/DI 10195327123864 (each) 40195327123865, (case), Lot Numbers: DYNJ81603; REF DYNJ81603: UDI/DI 10195327123864 (each) 40195327123865, (case), Lot Numbers: DYNJ81603; REF DYNJ81603: UDI/DI 10195327123864 (each) 40195327123865, (case), Lot Numbers: DYNJ81603; REF DYNJ82871: UDI/DI 10195327212940 (each) 40195327212941, (case), Lot Numbers: DYNJ82871; REF DYNJ82871: UDI/DI 10195327212940 (each) 40195327212941, (case), Lot Numbers: DYNJ82871; REF DYNJ82871: UDI/DI 10195327212940 (each) 40195327212941, (case), Lot Numbers: DYNJ82871; REF DYNJ84604: UDI/DI 10195327386061 (each) 40195327386062, (case), Lot Numbers: DYNJ84604; REF DYNJ85113: UDI/DI 10195327460778 (each) 40195327460779, (case), Lot Numbers: DYNJ85113; REF DYNJ85614: UDI/DI 10195327523794 (each) 40195327523795, (case), Lot Numbers: DYNJ85614; REF DYNJ86151: UDI/DI 10195327598099 (each) 40195327598090, (case), Lot Numbers: DYNJ86151; REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F; REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F; REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F; REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F; REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F; REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G; REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G; REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G; REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G; REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G; REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F; REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F; REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F; REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F; REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F; REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F; REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F; REF DYNJ900709D: UDI/DI 10195327635312 (each) 40195327635313, (case), Lot Numbers: DYNJ900709D; REF DYNJ900709D: UDI/DI 10195327635312 (each) 40195327635313, (case), Lot Numbers: DYNJ900709D; REF DYNJ900710C: UDI/DI 10193489951325 (each) 40193489951326, (case), Lot Numbers: DYNJ900710C; REF DYNJ900710D: UDI/DI 10195327635329 (each) 40195327635320, (case), Lot Numbers: DYNJ900710D; REF DYNJ900710D: UDI/DI 10195327635329 (each) 40195327635320, (case), Lot Numbers: DYNJ900710D; REF DYNJ900723C: UDI/DI 10193489951622 (each) 40193489951623, (case), Lot Numbers: DYNJ900723C; REF DYNJ900723C: UDI/DI 10193489951622 (each) 40193489951623, (case), Lot Numbers: DYNJ900723C; REF DYNJ900723C: UDI/DI 10193489951622 (each) 40193489951623, (case), Lot Numbers: DYNJ900723C; REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D; REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D; REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D; REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D; REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D; REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I; REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I; REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I; REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I; REF DYNJ904090D: UDI/DI 10193489282825 (each) 40193489282826, (case), Lot Numbers: DYNJ904090D; REF DYNJ904090D: UDI/DI 10193489282825 (each) 40193489282826, (case), Lot Numbers: DYNJ904090D; REF DYNJ904090D: UDI/DI 10193489282825 (each) 40193489282826, (case), Lot Numbers: DYNJ904090D; REF DYNJ904306G: UDI/DI 10195327406370 (each) 40195327406371, (case), Lot Numbers: DYNJ904306G; REF DYNJ904306G: UDI/DI 10195327406370 (each) 40195327406371, (case), Lot Numbers: DYNJ904306G; REF DYNJ904699G: UDI/DI 10195327169299 (each) 40195327169290, (case), Lot Numbers: DYNJ904699G; REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F; REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F; REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F; REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F; REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F; REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F; REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D; REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D; REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D; REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D; REF DYNJ906659F: UDI/DI 10193489999495 (each) 40193489999496, (case), Lot Numbers: DYNJ906659F; REF DYNJ907612A: UDI/DI 10195327059132 (each) 40195327059133, (case), Lot Numbers: DYNJ907612A; REF DYNJ907612A: UDI/DI 10195327059132 (each) 40195327059133, (case), Lot Numbers: DYNJ907612A; REF DYNJ907614A: UDI/DI 10195327059149 (each) 40195327059140, (case), Lot Numbers: DYNJ907614A; REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A; REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A; REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A; REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A; REF DYNJ908065A: UDI/DI 10195327125707 (each) 40195327125708, (case), Lot Numbers: DYNJ908065A; REF DYNJ908065A: UDI/DI 10195327125707 (each) 40195327125708, (case), Lot Numbers: DYNJ908065A; REF DYNJ908065A: UDI/DI 10195327125707 (each) 40195327125708, (case), Lot Numbers: DYNJ908065A; REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A; REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A; REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A; REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A; REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A; REF DYNJ909200: UDI/DI 10195327304034 (each) 40195327304035, (case), Lot Numbers: DYNJ909200; REF DYNJ909570A: UDI/DI 10195327435530 (each) 40195327435531, (case), Lot Numbers: DYNJ909570A; REF DYNJ909570B: UDI/DI 10198459176067 (each) 40198459176068, (case), Lot Numbers: DYNJ909570B; REF DYNJVA900011D: UDI/DI 10195327550639 (each) 40195327550630, (case), Lot Numbers: DYNJVA900011D; REF PHS397085007F: UDI/DI 10195327454128 (each) 40195327454129, (case), Lot Numbers: PHS397085007F; REF PHS397101008F: UDI/DI 10195327454241 (each) 40195327454242, (case), Lot Numbers: PHS397101008F; REF PHS397123008F: UDI/DI 10195327454135 (each) 40195327454136, (case), Lot Numbers: PHS397123008F.

Distribution pattern

US Nationwide distribution.

device · product 8 of 20

MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597

Z-0518-2026
Recall number
Z-0518-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
12 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

UDI/DI 10195327124007 (each), 40195327124008 (case), Lot Numbers: 23JBR560

Distribution pattern

US Nationwide distribution.

device · product 9 of 20

MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #87-RF, REF DYNJ27319V; 7) BREAST AUGMENTATION PACK, REF DYNJ33977M; 8) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 9) BREAST PACK, REF DYNJ57527C; 10) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 11) ISS MAJOR BREAST PACK, REF DYNJ58668D; 12) CHEST/BREAST PACK, REF DYNJ66495A; 13) MAJOR PLASTICS PACK, REF DYNJ67968B; 14) BREAST PACK, REF DYNJ68464A; 15) BREAST PACK, REF DYNJ68464B; 16) PLASTIC PACK, REF DYNJ83856; 17) PLASTIC PACK, REF DYNJ83856A; 18) PLASTIC PACK, REF DYNJ83856B; 19) BREAST PACK, REF DYNJ84332A; 20) ACH PLASTICS BREAST PK-LF, REF DYNJ85111; 21) BREAST-CHEST, REF DYNJ900294L; 22) PLASTICS MASTECTOMY, REF DYNJ904966C; 23) BREAST PLASTIC, REF DYNJ906638B; 24) BREAST-CHEST, REF DYNJ907141B; 25) BREAST RECONSTRUCTION PACK, REF DYNJ907791B; 26) BREAST RECONSTRUCTION PACK, REF DYNJ907791D; 27) BREAST HERNIA, REF DYNJ908058A; 28) CHEST BREAST KIT, REF DYNJ909203A; 29) PLASTIC, REF DYNJ909410; 30) PLASTIC, REF DYNJ910440; 31) BREAST -LF, REF DYNJ9426113N; 32) GP-PLASTIC BREAST ABD PACK-LF, REF PHS397064007D.

Z-0519-2026
Recall number
Z-0519-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
4214 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

REF CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23FBP157; REF CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23GBM569; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 23LBN523; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24BBA266; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24CBS676; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24EBM454; REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMA639; REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMF507; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23GMI327; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23JMC006; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMA065; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMC367; REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24DMF699; REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24EMA236; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBI654; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBJ925; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23HBZ090; REF DYNJ33977M: UDI/DI 10195327422523 (each), 40195327422524 (case), Lot Number 23HBB046; REF DYNJ44852M: UDI/DI 10195327325220 (each), 40195327325221 (case), Lot Number 23HME689; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23GBA730; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23HBG731; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23HBT208; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23IBG463; REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 23KMI230; REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 24BME250; REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 24DME657; REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 23LMB473; REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 24AMH995; REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 24EMA379; REF DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case), Lot Number 23DMG612; REF DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case), Lot Number 23JMD696; REF DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case), Lot Number 23IMG461; REF DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case), Lot Number 24BMC283; REF DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case), Lot Number 23LBN305; REF DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case), Lot Number 24CBE964; REF DYNJ68464B: UDI/DI 10195327666224 (each), 40195327666225 (case), Lot Number 24DBP960; REF DYNJ83856: UDI/DI 10195327318253 (each), 40195327318254 (case), Lot Number 23GBV076; REF DYNJ83856A: UDI/DI 10195327520830 (each), 40195327520831 (case), Lot Number 23LBD001; REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24CBA468; REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24CBJ818; REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24EBC307; REF DYNJ84332A: UDI/DI 10198459022432 (each), 40198459022433 (case), Lot Number 24EMI031; REF DYNJ85111: UDI/DI 10195327460808 (each), 40195327460809 (case), Lot Number 23JBC629; REF DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case), Lot Number 24CBI707; REF DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case), Lot Number 24EBP322; REF DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case), Lot Number 24IBK581; REF DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case), Lot Number 24BBI057; REF DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case), Lot Number 24CBA316; REF DYNJ904966C: UDI/DI 10195327574000 (each), 40195327574001 (case), Lot Number 24DBS660; REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 23KBW113; REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 24BBA200; REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 24CBG796; REF DYNJ906638B: UDI/DI 10195327421410 (each), 40195327421411 (case), Lot Number 24CBL477; REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 23HBA138; REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 23LBP102; REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24ABO369; REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24BBO672; REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24CBL486; REF DYNJ907141B: UDI/DI 10195327450434 (each), 40195327450435 (case), Lot Number 24DBM827; REF DYNJ907791B: UDI/DI 10195327185237 (each), 40195327185238 (case), Lot Number 23EBN537; REF DYNJ907791B: UDI/DI 10195327185237 (each), 40195327185238 (case), Lot Number 23EBT257; REF DYNJ907791D: UDI/DI 10195327439859 (each), 40195327439850 (case), Lot Number 23LBK712; REF DYNJ907791D: UDI/DI 10195327439859 (each), 40195327439850 (case), Lot Number 24DBV324; REF DYNJ908058A: UDI/DI 10195327125424 (each), 40195327125425 (case), Lot Number 24CBI553; REF DYNJ908058A: UDI/DI 10195327125424 (each), 40195327125425 (case), Lot Number 24DBI370; REF DYNJ909203A: UDI/DI 10195327363512 (each), 40195327363513 (case), Lot Number 24ABK735; REF DYNJ909203A: UDI/DI 10195327363512 (each), 40195327363513 (case), Lot Number 24DBR411; REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 23FMB748; REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 23FMI603; REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 23LMH380; REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 24BMG608; REF DYNJ909410: UDI/DI 10195327338473 (each), 40195327338474 (case), Lot Number 24DMD838; REF DYNJ910440: UDI/DI 10195327685973 (each), 40195327685974 (case), Lot Number 24EBJ004; REF DYNJ9426113N: UDI/DI 10195327371449 (each), 40195327371440 (case), Lot Number 23KMI086; REF DYNJ9426113N: UDI/DI 10195327371449 (each), 40195327371440 (case), Lot Number 23LMH856; REF PHS397064007D: UDI/DI 10195327454111 (each), 40195327454112 (case), Lot Number 23HDB143.

Distribution pattern

US Nationwide distribution.

device · product 10 of 20

MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.

Z-0520-2026
Recall number
Z-0520-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
1921 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF DYNJ37698L: UDI/DI 10195327435523 (each) 40195327435524, (case), Lot Numbers: 23KMG076, 24AMA944, 24FMA911; 2) REF DYNJ50123D: UDI/DI 10195327201999 (each) 40195327201990, (case), Lot Numbers: 23FBP789, 24ABG308, 24BBQ467, 24DBP157; 3) REF DYNJ59816A: UDI/DI 10195327331573 (each) 40195327331574, (case), Lot Numbers: 23GBR142, 23IBJ642, 23LBD170, 23LBM241; 4) REF DYNJ68217A: UDI/DI 10195327352523 (each) 40195327352524, (case), Lot Numbers: 23EMB405, 23IMH248.

Distribution pattern

US Nationwide distribution.

device · product 11 of 20

MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJOR ABDOMINAL CDS, REF CDS983908Q; 8) LOWER EXTREMITY CDS, REF CDS983909Q; 9) GENERAL SURGERY CDS, REF CDS983914M; 10) GENERAL ORTHO CDS, REF CDS983915N; 11) GENERAL LAP, REF CDS984251O; 12) ROBOTIC, REF CDS984262O; 13) HYPOSPADIUS PACK, REF DYNJ00282Q; 14) MINOR HARPER PACK-LF, REF DYNJ0161694F; 15) THROMBECTOMY HARPER PACK-LF, REF DYNJ0161832F; 16) MAJOR COMPONENT HARPER PACK-LF, REF DYNJ0161949C; 17) MINOR PACK-LF, REF DYNJ0259893T; 18) TOTAL KNEE PACK LF, REF DYNJ0368519AA; 19) TOTAL KNEE PACK LF, REF DYNJ0368519Y; 20) PEDIATRIC BASIC PACK-LF, REF DYNJ0406353N; 21) DONOR FREE FLAP PACK-LF, REF DYNJ0426069O; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069P; 23) VASCULAR PACK-LF, REF DYNJ0429345R; 24) GENERAL PACK-LF, REF DYNJ0506906S; 25) BASIC PACK-LF, REF DYNJ0519294K; 26) TOTAL HIP PACK-LF, REF DYNJ0537284AC; 27) TOTAL HIP PACK-LF, REF DYNJ0537284AD; 28) BASIC MAJOR PACK-LF, REF DYNJ0537337AA; 29) BASIC MAJOR PACK-LF, REF DYNJ0537337Y; 30) BASIC GENERAL PACK-LF, REF DYNJ14004N; 31) MVFF/FIBU #54-RF, REF DYNJ21927S; 32) AUGMENTATION #87-RF, REF DYNJ27319W; 33) BASIC SET-UP, REF DYNJ34979B; 34) BASIC PACK, REF DYNJ35834D; 35) MINOR SINGLE BASIN PACK, REF DYNJ37698M; 36) ISSAQUAH PEDIATRIC PACK, REF DYNJ39001F; 37) TOTAL JOINT PACK, REF DYNJ40982F; 38) BASIC PACK, REF DYNJ42791F; 39) TOTAL JOINT PACK, REF DYNJ42793F; 40) RRP PACK, REF DYNJ44109F; 41) CENTRACARE BASIC PACK, REF DYNJ44858J; 42) DONOR PACK, REF DYNJ44865G; 43) UROLOGY RECONSTRUCTION PACK, REF DYNJ44866P; 44) UROLOGY PACK, REF DYNJ44899R; 45) ENDOCRINE PACK-RF, REF DYNJ47131F; 46) ENDOCRINE PACK-RF, REF DYNJ47131G; 47) ORTHO MAJOR, REF DYNJ48131K; 48) ENDO BLADDER PACK, REF DYNJ49672M; 49) ORTHO SPINE SUPPLEMENT PACK-LF, REF DYNJ51445B; 50) MINOR GENERAL PACK, REF DYNJ53036J; 51) ACL PACK, REF DYNJ54634I; 52) READY SET CLOSE PACK, REF DYNJ57214C; 53) KIDNEY TRANSPLANT, REF DYNJ57455C; 54) TOTAL HIP PACK, REF DYNJ58563F; 55) TOTAL HIP PACK, REF DYNJ58563G; 56) TOTAL KNEE PACK, REF DYNJ58564F; 57) TRANSPLANT PACK, REF DYNJ59201D; 58) PACK RECTAL, REF DYNJ60156C; 59) C-SECTION PK CABRINI, REF DYNJ60577B; 60) MINI KIT PACK CABRINI, REF DYNJ60579B; 61) MAJOR GENERAL CHRISTUS, REF DYNJ61184D; 62) PK CUST BASIC PK CHRISTUS, REF DYNJ61647B; 63) THORACIC PACK, REF DYNJ62015B; 64) MAJOR GENERAL PACK, REF DYNJ62397B; 65) VASCULAR PACK, REF DYNJ62683D; 66) GENDER AFFIRMING SURGERY, REF DYNJ66252C; 67) GENDER AFFIRMING SURGERY, REF

Z-0521-2026
Recall number
Z-0521-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
20941 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

REF 24BBC860: UDI/DI 10195327601492 (each), 40195327601493 (case), Lot Numbers: 24BBC860; REF 24BBU607: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24BBU607; REF 24CBU583: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24CBU583; REF 24EBE546: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24EBE546; REF 23GBF733: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 23GBF733; REF 24ABG140: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24ABG140; REF 24BBN521: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24BBN521; REF 24CBR696: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24CBR696; REF 24EBK857: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24EBK857; REF 24ABH200: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24ABH200; REF 24BBG787: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24BBG787; REF 24CBI679: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24CBI679; REF 23GBS700: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 23GBS700; REF 24ABG363: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 24ABG363; REF 24BBH950: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBH950; REF 24BBR420: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBR420; REF 24CBV474: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24CBV474; REF 24EBS619: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24EBS619; REF 24ABQ767: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABQ767; REF 24ABS333: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABS333; REF 24EBP558: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24EBP558; REF 24ABL655: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24ABL655; REF 24CBI698: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24CBI698; REF 24EBJ019: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24EBJ019; REF 24FBE329: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBE329; REF 24FBI206: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBI206; REF 24BBC411: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24BBC411; REF 24CBD731: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24CBD731; REF 24EBM175: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24EBM175; REF 24BBF155: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24BBF155; REF 24CBU894: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24CBU894; REF 24FBE659: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24FBE659; REF 24BBE394: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBE394; REF 24BBO665: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBO665; REF 24BBV851: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBV851; REF 23EMF844: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23EMF844; REF 23HMD598: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23HMD598; REF 23FDA733: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23FDA733; REF 23HDB247: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23HDB247; REF 23EDA481: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23EDA481; REF 23FDA681: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23FDA681; REF 23FDB248: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB248; REF 23FDB439: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB439; REF 23FDC293: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDC293; REF 23JMD699: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23JMD699; REF 23KMG018: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23KMG018; REF 23LMB676: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23LMB676; REF 24CMA286: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 24CMA286; REF 24EMH397: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 24EMH397; REF 24BBG478: UDI/DI 10195327618360 (each), 40195327618361 (case), Lot Numbers: 24BBG478; REF 24DBA379: UDI/DI 10195327618360 (each), 40195327618361 (case), Lot Numbers: 24DBA379; REF 23LBE978: UDI/DI 10195327556495 (each), 40195327556496 (case), Lot Numbers: 23LBE978; REF 23LBN137: UDI/DI 10195327556495 (each), 40195327556496 (case), Lot Numbers: 23LBN137; REF 25CMF710: UDI/DI 10198459237010 (each), 40198459237011 (case), Lot Numbers: 25CMF710; REF 24AMG978: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24AMG978; REF 24CMF532: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24CMF532; REF 24CMF532A: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24CMF532A; REF 24DMD291: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMD291; REF 24DMJ889: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMJ889; REF 24DMJ889A: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMJ889A; REF 24FMA003: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24FMA003; REF 24AMC190: UDI/DI 10195327587567 (each), 40195327587568 (case), Lot Numbers: 24AMC190; REF 23LMH286: UDI/DI 10195327356774 (each), 40195327356775 (case), Lot Numbers: 23LMH286; REF 24FMG970: UDI/DI 10195327356774 (each), 40195327356775 (case), Lot Numbers: 24FMG970; REF 23GMG601: UDI/DI 10195327084851 (each), 40195327084852 (case), Lot Numbers: 23GMG601; REF 23LBL866: UDI/DI 10195327556488 (each), 40195327556489 (case), Lot Numbers: 23LBL866; REF 24DBF254: UDI/DI 10195327618377 (each), 40195327618378 (case), Lot Numbers: 24DBF254; REF 24DBS437: UDI/DI 10195327618377 (each), 40195327618378 (case), Lot Numbers: 24DBS437; REF 23LBJ656: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 23LBJ656; REF 24ABO017: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24ABO017; REF 24BBK221: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24BBK221; REF 24BBV641: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24BBV641; REF 24DBV052: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24DBV052; REF 23HMC872: UDI/DI 10195327418502 (each), 40195327418503 (case), Lot Numbers: 23HMC872; REF 23FBD394: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23FBD394; REF 23GBA320: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23GBA320; REF 23HBP909: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23HBP909; REF 23KBI977: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23KBI977; REF 24ABP890: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 24ABP890; REF 24ABW268: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24ABW268; REF 24BBN342: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24BBN342; REF 24CBV435: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24CBV435; REF 24BBT429: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24BBT429; REF 24DBO680: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24DBO680; REF 24EBB580: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24EBB580; REF 23IMB907: UDI/DI 10193489733006 (each), 40193489733007 (case), Lot Numbers: 23IMB907; REF 23LMB648: UDI/DI 10193489733006 (each), 40193489733007 (case), Lot Numbers: 23LMB648; REF 23FMI945: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23FMI945; REF 23GMC968: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23GMC968; REF 23GMD789: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23GMD789; REF 23HMC393: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23HMC393; REF 24LMD228: UDI/DI 10198459170287 (each), 40198459170288 (case), Lot Numbers: 24LMD228; REF 24AMC149: UDI/DI 10195327529727 (each), 40195327529728 (case), Lot Numbers: 24AMC149; REF 24EBP778: UDI/DI 10195327651947 (each), 40195327651948 (case), Lot Numbers: 24EBP778; REF 23KMF307: UDI/DI 10193489827538 (each), 40193489827539 (case), Lot Numbers: 23KMF307; REF 24BBO859: UDI/DI 10193489827538 (each), 40193489827539 (case), Lot Numbers: 24BBO859; REF 24CBP376: UDI/DI 10195327653538 (each), 40195327653539 (case), Lot Numbers: 24CBP376; REF 24DBK029: UDI/DI 10195327653538 (each), 40195327653539 (case), Lot Numbers: 24DBK029; REF 25BMA362: UDI/DI 10198459157882 (each), 40198459157883 (case), Lot Numbers: 25BMA362; REF 23EBH918: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23EBH918; REF 23FBP180: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23FBP180; REF 23GBI066: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23GBI066; REF 23GBI768: UDI/DI 10195327127633 (each), 40195327127634 (case), Lot Numbers: 23GBI768; REF 23FDB675: UDI/DI 10195327127640 (each), 40195327127641 (case), Lot Numbers: 23FDB675; REF 23HMF595: UDI/DI 10195327127763 (each), 40195327127764 (case), Lot Numbers: 23HMF595; REF 23JMB651: UDI/DI 10195327127763 (each), 40195327127764 (case), Lot Numbers: 23JMB651; REF 23FBS399: UDI/DI 10195327104481 (each), 40195327104482 (case), Lot Numbers: 23FBS399; REF 23GBU051: UDI/DI 10195327104481 (each), 40195327104482 (case), Lot Numbers: 23GBU051; REF 23LBQ322: UDI/DI 10195327580445 (each), 40195327580446 (case), Lot Numbers: 23LBQ322; REF 24ABB411: UDI/DI 10195327580445 (each), 40195327580446 (case), Lot Numbers: 24ABB411; REF 24ABE534: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24ABE534; REF 24ABM168: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24ABM168; REF 24BBP488: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24BBP488; REF 23EDA769: UDI/DI 10195327298241 (each), 40195327298242 (case), Lot Numbers: 23EDA769; REF 25CME293: UDI/DI 10198459004162 (each), 40198459004163 (case), Lot Numbers: 25CME293; REF 24DBQ236: UDI/DI 10195327683641 (each), 40195327683642 (case), Lot Numbers: 24DBQ236; REF 24BME129: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24BME129; REF 24CMA954: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24CMA954; REF 24DMF816: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24DMF816; REF 24FMG334: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24FMG334; REF 23GBF882: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 23GBF882; REF 23LBF959: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 23LBF959; REF 24FMC274: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 24FMC274; REF 24FME602: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 24FME602; REF 23LBQ748: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 23LBQ748; REF 24ABV036: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 24ABV036; REF 24DBA039: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 24DBA039; REF 24BME600: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24BME600; REF 24CMD450: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24CMD450; REF 24FMH050: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24FMH050; REF 25AMB211: UDI/DI 10198459218798 (each), 40198459218799 (case), Lot Numbers: 25AMB211; REF 24CMJ290: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24CMJ290; REF 24DMJ919: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24DMJ919; REF 24FMG191: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24FMG191; REF 24ALA025: UDI/DI 10195327465490 (each), 40195327465491 (case), Lot Numbers: 24ALA025; REF 23KMJ737: UDI/DI 10195327425425 (each), 40195327425426 (case), Lot Numbers: 23KMJ737; REF 23KBF763: UDI/DI 10195327547721 (each), 40195327547722 (case), Lot Numbers: 23KBF763; REF 23KBF750: UDI/DI 10195327547752 (each), 40195327547753 (case), Lot Numbers: 23KBF750; REF 23KBE945: UDI/DI 10195327543204 (each), 40195327543205 (case), Lot Numbers: 23KBE945; REF 23KBV078: UDI/DI 10195327506179 (each), 40195327506170 (case), Lot Numbers: 23KBV078; REF 23LBV307: UDI/DI 10195327506179 (each), 40195327506170 (case), Lot Numbers: 23LBV307; REF 23HBI144: UDI/DI 10195327401061 (each), 40195327401062 (case), Lot Numbers: 23HBI144; REF 23JBD981: UDI/DI 10195327401061 (each), 40195327401062 (case), Lot Numbers: 23JBD981; REF 23DBJ748: UDI/DI 10193489873917 (each), 40193489873918 (case), Lot Numbers: 23DBJ748; REF 23LBF100: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 23LBF100; REF 24ABP681: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABP681; REF 24ABQ390: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABQ390; REF 24ABR344: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABR344; REF 24ABT457: UDI/DI 10195327573508 (each), 40195327573509 (case), Lot Numbers: 24ABT457; REF 24BBN976: UDI/DI 10195327573508 (each), 40195327573509 (case), Lot Numbers: 24BBN976; REF 24DBN478: UDI/DI 10195327665371 (each), 40195327665372 (case), Lot Numbers: 24DBN478; REF 24EBB279: UDI/DI 10195327665371 (each), 40195327665372 (case), Lot Numbers: 24EBB279; REF 24DBP727: UDI/DI 10195327653378 (each), 40195327653379 (case), Lot Numbers: 24DBP727; REF 23HMC391: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23HMC391; REF 23HMC391A: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23HMC391A; REF 23IMF472: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23IMF472; REF 23EBC299: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23EBC299; REF 23EBD393: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23EBD393; REF 23FBQ644: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23FBQ644; REF 23FBR335: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23FBR335; REF 24ABR941: UDI/DI 10195327578480 (each), 40195327578481 (case), Lot Numbers: 24ABR941; REF 23HMD614: UDI/DI 10195327352585 (each), 40195327352586 (case), Lot Numbers: 23HMD614; REF 23HMD699: UDI/DI 10195327352547 (each), 40195327352548 (case), Lot Numbers: 23HMD699; REF 23JMA869: UDI/DI 10195327512026 (each), 40195327512027 (case), Lot Numbers: 23JMA869; REF 24ABP075: UDI/DI 10195327542078 (each), 40195327542079 (case), Lot Numbers: 24ABP075; REF 23HBF482: UDI/DI 10195327422547 (each), 40195327422548 (case), Lot Numbers: 23HBF482; REF 23GBM786: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23GBM786; REF 23JBF877: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23JBF877; REF 23KBF328: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23KBF328; REF 24ABR880: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 24ABR880; REF 23EBO892: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 23EBO892; REF 23GBN260: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 23GBN260; REF 24ABU344: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 24ABU344; REF 24BBA167: UDI/DI 10195327618599 (each), 40195327618590 (case), Lot Numbers: 24BBA167; REF 23LBM994: UDI/DI 10195327569396 (each), 40195327569397 (case), Lot Numbers: 23LBM994; REF 24DBQ086: UDI/DI 10195327689780 (each), 40195327689781 (case), Lot Numbers: 24DBQ086; REF 24FMH614: UDI/DI 10198459046179 (each), 40198459046170 (case), Lot Numbers: 24FMH614; REF 23JBJ315: UDI/DI 10195327484453 (each), 40195327484454 (case), Lot Numbers: 23JBJ315; REF 23LBL460: UDI/DI 10195327484453 (each), 40195327484454 (case), Lot Numbers: 23LBL460; REF 24BBF647: UDI/DI 10195327556501 (each), 40195327556502 (case), Lot Numbers: 24BBF647; REF 24KMD557: UDI/DI 10195327684976 (each), 40195327684977 (case), Lot Numbers: 24KMD557; REF 24FMC551: UDI/DI 10195327697471 (each), 40195327697472 (case), Lot Numbers: 24FMC551; REF 23GBK061: UDI/DI 10193489915112 (each), 40193489915113 (case), Lot Numbers: 23GBK061; REF 24ABP586: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24ABP586; REF 24BBQ527: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24BBQ527; REF 24CBM211: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24CBM211; REF 24ALA564: UDI/DI 10195327540388 (each), 40195327540389 (case), Lot Numbers: 24ALA564; REF 23JMH334: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23JMH334; REF 23KMC378: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23KMC378; REF 23LMG820: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23LMG820; REF 24AME239: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24AME239; REF 24CMA078: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24CMA078; REF 24DME143: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24DME143; REF 24EMA859: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24EMA859; REF 23IDA164: UDI/DI 10193489282818 (each), 40193489282819 (case), Lot Numbers: 23IDA164; REF 23EDB532: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23EDB532; REF 23FDB404: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23FDB404; REF 23IDA596: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23IDA596; REF 24BBB064: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24BBB064; REF 24BBH257: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24BBH257; REF 24DBL795: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24DBL795; REF 23LBE717: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 23LBE717; REF 24ABK008: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 24ABK008; REF 24FBA280: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 24FBA280; REF 23JBE392: UDI/DI 10195327344412 (each), 40195327344413 (case), Lot Numbers: 23JBE392; REF 23EBP184: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23EBP184; REF 23FBO482: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23FBO482; REF 23HBE220: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23HBE220; REF 24CMF366: UDI/DI 10195327651336 (each), 40195327651337 (case), Lot Numbers: 24CMF366; REF 24EMJ009: UDI/DI 10195327651336 (each), 40195327651337 (case), Lot Numbers: 24EMJ009; REF 23HBN222: UDI/DI 10195327313449 (each), 40195327313440 (case), Lot Numbers: 23HBN222; REF 24DBU838: UDI/DI 10195327622374 (each), 40195327622375 (case), Lot Numbers: 24DBU838; REF 24FBD404: UDI/DI 10195327622374 (each), 40195327622375 (case), Lot Numbers: 24FBD404; REF 24BBT683: UDI/DI 10195327606589 (each), 40195327606580 (case), Lot Numbers: 24BBT683; REF 24GBH489: UDI/DI 10195327606589 (each), 40195327606580 (case), Lot Numbers: 24GBH489; REF 23EME689: UDI/DI 10193489877328 (each), 40193489877329 (case), Lot Numbers: 23EME689; REF 24BMC531: UDI/DI 10195327617769 (each), 40195327617760 (case), Lot Numbers: 24BMC531; REF 23HDB171: UDI/DI 10195327454180 (each), 40195327454181 (case), Lot Numbers: 23HDB171; REF 23HDB144: UDI/DI 10195327454210 (each), 40195327454211 (case), Lot Numbers: 23HDB144; REF 23JDB494: UDI/DI 10195327454210 (each), 40195327454211 (case), Lot Numbers: 23JDB494.

Distribution pattern

US Nationwide distribution.

device · product 12 of 20

MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.

Z-0522-2026
Recall number
Z-0522-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
1315 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23LMG063; 2) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 24ABG356, 24CBH117, 24DBJ347; 3) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23JMC956, 23KMF585, 24AMB974; 4) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 23EBS176, 23GBF899, 23HBZ085; 5) REF DYNJ44882M, UDI/DI 10195327382803 (each) 40195327382804 (case), Lot Numbers: 23FDA522, 23GDB903; 6) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers: 23IBD913, 23IBD914, 23JBL889, 24ABE596, 24BBL042, 24CBH196, 24DBU825.

Distribution pattern

US Nationwide distribution.

device · product 13 of 20

MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

Z-0523-2026
Recall number
Z-0523-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
424 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF DYNJ0161768G: UDI/DI 10195327404567 (each) 40195327404568 (case), Lot Numbers: 23FDA201, 23HDB248; 2) REF DYNJ67757B: UDI/DI 10195327228002 (each) 40195327228003 (case), Lot Numbers: 23EBK325, 23HBM888, 23IBP459, 23JBV413.

Distribution pattern

US Nationwide distribution.

device · product 14 of 20

MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 7) LAP-GYN PACK, REF DYNJ44876M; 8) ROBOT PACK, REF DYNJ45184F; 9) GYN LAP PACK, REF DYNJ52524D; 10) GYN LAP PACK, REF DYNJ64234C; 11) GYN DAVINCI PACK, REF DYNJ65373A; 12) ROBOT PACK, REF DYNJ67190C; 13) ROBOTIC PACK, REF DYNJ86154; 14) GYN LAPAROTOMY, REF DYNJ900296K; 15) ROBOT THOR, REF DYNJ900300K; 16) ROBOT URO, REF DYNJ900301K; 17) SM DAVINCI, REF DYNJ903539G; 18) ROBOTIC PACK-LF, REF DYNJ904250I; 19) ROBOTIC-LF, REF DYNJ907910B; 20) GP-ROBOTIC PACK-LF, REF PHS504647004G.

Z-0524-2026
Recall number
Z-0524-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
2844 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 23LBV707; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD429; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD498; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24DBK836; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24HBE577; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23HBO463; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23JBF467; REF CDS984262N: UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 24ABP835; REF CDS984262P: UDI/DI 10195327647704 (each) 40195327647705 (case), Lot Numbers: 24CBK422; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23GBT512; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23HBI619; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23LBN095; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24BBR322; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBA027; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBT103; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24EBG556; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23GBO806; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23HBJ772; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23EDB052; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB708; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB759; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23DBJ363; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23EBU559; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23HBL687; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23JBD927; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 23LBG811; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 24BBQ970; REF DYNJ64234C: UDI/DI 10195327486921 (each) 40195327486922 (case), Lot Numbers: 23JMA672; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23EMH332; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23FMD177; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23HMB194; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBJ145; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBK217; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23FBS005; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23GBP632; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23IBP551; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23JBH964; REF DYNJ86154: UDI/DI 10195327598112 (each) 40195327598113 (case), Lot Numbers: 24CBA421; REF DYNJ900296K: UDI/DI 10195327554088 (each) 40195327554089 (case), Lot Numbers: 23LBG402; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBF280; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBO223; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24ABV771; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24CBC856; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24ABS777; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24BBB142; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24CBI705; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24EBN319; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC169; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC442; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMG251; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KMC642; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KME178; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23LMC669; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24ABT614; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24DBM183; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24EBJ705; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24ABC736; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24DBD770; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24EBH118; REF PHS504647004G: UDI/DI 10195327454142 (each) 40195327454143 (case), Lot Numbers: 23HDB026.

Distribution pattern

US Nationwide distribution.

device · product 15 of 20

MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O

Z-0525-2026
Recall number
Z-0525-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
120 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

UDI/DI: 10195327412067 (each) 40195327412068 (case), Lot Numbers: 23GMC962

Distribution pattern

US Nationwide distribution.

device · product 16 of 20

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECTION PACK-LF, REF DYNJ0551409P; 8) C-SECTION PACK-LF, REF DYNJ07836R; 9) C-SECTION, REF DYNJ14103C; 10) C-SECTION PACK, REF DYNJ19417R; 11) C-SECTION PACK-LF, REF DYNJ33059B; 12) C-SECTION PACK SC-LF, REF DYNJ38063D; 13) C-SECTION PACK SC-LF, REF DYNJ38700G; 14) C-SECTION PACK-LF, REF DYNJ38845D; 15) C-SECTION PACK-LF, REF DYNJ38845F; 16) C-SECTION PACK, REF DYNJ44679L; 17) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 18) C SECTION PACK, REF DYNJ48087I; 19) C-SECTION I, REF DYNJ51354B; 20) C-SECTION SAFETY PACK, REF DYNJ52481B; 21) C-SECTION SMMC, REF DYNJ59457B; 22) C-SECTION PACK, REF DYNJ59825A; 23) PK CUST C-SECTION ST MICH, REF DYNJ60544C; 24) C SECTION PACK, REF DYNJ64377D; 25) C-SECTION PACK, REF DYNJ64505B; 26) C SECTION SHARED, REF DYNJ64775C; 27) LDRP-C SECTION PACK-LF, REF DYNJ64834A; 28) LDRP-C SECTION PACK-LF, REF DYNJ64834B; 29) C-SECTION PACK-LF, REF DYNJ65031D; 30) C SECTION PK, REF DYNJ65403A; 31) C SECTION PACK-LF, REF DYNJ65765A; 32) C-SECTION PACK-LF, REF DYNJ69445; 33) C-SECTION PACK-LF, REF DYNJ69445A; 34) C SECTION DELIVERY PACK, REF DYNJ81604A; 35) C SECTION DELIVERY PACK, REF DYNJ81604B; 36) C SECTION PACK, REF DYNJ82949; 37) C-SECTION ADD ON PACK, REF DYNJ83507; 38) C-SECTION PACK, REF DYNJ83980; 39) C SECTION ACCESS, REF DYNJ85612; 40) ISSAQUAH C-SECTION PACK-LF, REF DYNJ85770; 41) C-SECTION PACK, REF DYNJ86173; 42) C-SECTION, REF DYNJ900266F; 43) C-SECTION, REF DYNJ903865D; 44) C-SECTION, REF DYNJ904612G; 45) C-SECTION, REF DYNJ904612I; 46) C-SECTION, REF DYNJ904653G; 47) C-SECTION, REF DYNJ904697F; 48) CDS C-SECTION CH, REF DYNJ906263D; 49) C SECTION, REF DYNJ908327; 50) C-SECTION -LF, REF DYNJ9932207R; 51) C-SECTION -LF, REF DYNJ9932207S; 52) C-SECTION PACK, REF DYNJV0322A; 53) GP-C SECTION PACK-LF, REF PHS396980007C.

Z-0526-2026
Recall number
Z-0526-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
11032 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23JBR313; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23KBB240; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24DBA895; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24EBI651; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23FBP399; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23HBP624; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23IBE037; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23JBC747; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 23LBM204; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24ABL069; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24CBM113; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24FBE246; REF DYNJ02577D, UDI/DI: 10193489958003 (each) 40193489958004 (case), Lot Numbers: 23EDA073; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23GBP147; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBD395; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBP685; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24BBV536; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24EBF239; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23HMD981; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23KBF163; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBH765; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBT798; REF DYNJ0551409P, UDI/DI: 10195327561871 (each) 40195327561872 (case), Lot Numbers: 24BBC833; REF DYNJ07836R, UDI/DI: 10195327349431 (each) 40195327349432 (case), Lot Numbers: 24BBH764; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 23LBC980; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABQ944; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABR003; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABV987; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24BBG949; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23GMF903; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23HMF589; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23JMB497; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23EBO244; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23FBR011; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBD673; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBH801; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23IBP528; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMF816; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMI790; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23EMG135; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23FMI968; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23GMI116; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23HMA195; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23JMC837; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 24BMB829; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23DMI785; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23EMJ326; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23GMD537; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23IMF534; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23KMB242; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 24BMC270; REF DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case), Lot Numbers: 23HBQ392; REF DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case), Lot Numbers: 23LBT819; REF DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case), Lot Numbers: 24CBM675; REF DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case), Lot Numbers: 24EBP120; REF DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case), Lot Numbers: 23EBK092; REF DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case), Lot Numbers: 23EBS759; REF DYNJ47808F, UDI/DI: 10195327232603 (each) 40195327232604 (case), Lot Numbers: 23GMI543; REF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24ABE884; REF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24BBI603; REF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24CBU107; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 23JME469; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 23KMH696; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 24DMD663; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 24KMD766; REF DYNJ52481B, UDI/DI: 10195327689773 (each) 40195327689774 (case), Lot Numbers: 24DBO831; REF DYNJ59457B, UDI/DI: 10195327446574 (each) 40195327446575 (case), Lot Numbers: 23KMD078; REF DYNJ59825A, UDI/DI: 10195327331610 (each) 40195327331611 (case), Lot Numbers: 23HLA627; REF DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case), Lot Numbers: 23EBD197; REF DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case), Lot Numbers: 23EBR612; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23EBB409; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23GBG734; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23HBM866; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23IBR809; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 23HBI631; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24ABI243; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24BBC533; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24DBO874; REF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23EDC402; REF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23FDC227; REF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23HDB277; REF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23IMG148; REF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23JME325; REF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23LMA555; REF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24AMF996; REF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24BMI121; REF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24CMF007; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 23KMI521; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 23LMF119; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24AMC075; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24CMI550; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24EMH988; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24FME482; REF DYNJ65403A, UDI/DI: 10193489417081 (each) 40193489417082 (case), Lot Numbers: 24ABS258; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23EBO612; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23HBR353; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23IBJ604; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23KBD084; REF DYNJ69445, UDI/DI: 10193489942514 (each) 40193489942515 (case), Lot Numbers: 23GBA532; REF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 23KBU661; REF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 24BBH876; REF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 24BBI439; REF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23DBJ057; REF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23EBN921; REF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23FBB765; REF DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case), Lot Numbers: 23GBK114; REF DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case), Lot Numbers: 23JBK156; REF DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case), Lot Numbers: 23EBM401; REF DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case), Lot Numbers: 23IBQ454; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23HBW089; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23IBK153; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23LBU485; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23LBV117; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 24DBR994; REF DYNJ83980, UDI/DI: 10195327323554 (each) 40195327323555 (case), Lot Numbers: 24ABR096; REF DYNJ85612, UDI/DI: 10195327523770 (each) 40195327523771 (case), Lot Numbers: 23LMF612; REF DYNJ85770, UDI/DI: 10195327546557 (each) 40195327546558 (case), Lot Numbers: 24AMG054; REF DYNJ86173, UDI/DI: 10195327609412 (each) 40195327609413 (case), Lot Numbers: 24CBA422; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 23LBG515; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 23LBQ424; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABG727; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABS178; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABW963; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24BBQ451; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24CBT653; REF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 23KMD690; REF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 23LMG846; REF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 24AMG510; REF DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case), Lot Numbers: 23LMC684; REF DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case), Lot Numbers: 24AMA761; REF DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case), Lot Numbers: 24CMH459; REF DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case), Lot Numbers: 24GMH592; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23HBH779; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23IBP238; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23JBS995; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23KBM075; REF DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case), Lot Numbers: 23EDB517; REF DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case), Lot Numbers: 23FDB192; REF DYNJ906263D, UDI/DI: 10195327344375 (each) 40195327344376 (case), Lot Numbers: 23HBJ335; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23HMD044; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23JMH952; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23KMF087; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 24AMB283; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23GMI390; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23KMJ296; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23LMH787; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 24BMJ492; REF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24DMG311; REF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24FMB530; REF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24HMJ414; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 23JMF237; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 23KMG863; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 24AMI231; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 24HMD222; REF PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case), Lot Numbers: 23GDB702; REF PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case), Lot Numbers: 23HDA942.

Distribution pattern

US Nationwide distribution.

device · product 17 of 20

MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 7) URO GYN, REF DYNJ50047G; 8) ISS VAG HYST PACK, REF DYNJ50315F; 9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B; 10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 11) LAVH, REF DYNJ900298L; 12) LITHOTOMY-LF, REF DYNJ900721C; 13) GP-T A H PACK-LF, REF PHS396954006G; 14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.

Z-0527-2026
Recall number
Z-0527-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
570 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF DYNJ0160684F: UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 23DDC245, 23GDC219; 2) REF DYNJ0425778O: UDI/DI 10198459082290 (each) 40198459082291 (case), Lot Numbers: 24LMF192; 3) REF DYNJ27434R: UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 24BBR389, 24CBH709; 4) REF DYNJ44848M: UDI/DI 10195327415952 (each) 40195327415953 (case), Lot Numbers: 23EDB911, 23FDC315, 23HDA180; 5) REF DYNJ44863Q: UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23FDB122, 23GDC100; 6) REF DYNJ44900P: UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 23DDB824, 23EDA215, 23FDB287; 7) REF DYNJ50047G: UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 24BBE163, 24DBO682; 8) REF DYNJ50315F: UDI/DI 10195327535353 (each) 40195327535354 (case), Lot Numbers: 23KMF190; 9) REF DYNJ60554B: UDI/DI 10195327361747 (each) 40195327361748 (case), Lot Numbers: 23EBD224, 23KBE886; 10) REF DYNJ67194B: UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23HBN435; 11) REF DYNJ900298L: UDI/DI 10195327554170 (each) 40195327554171 (case), Lot Numbers: 23LBF269, 23LBT933, 24BBT248; 12) REF DYNJ900721C: UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers: 23HBW996; 13) REF PHS396954006G: UDI/DI 10195327454159 (each) 40195327454150 (case), Lot Numbers: 23HDB088; 14) REF PHS396975006F: UDI/DI 10195327454166 (each) 40195327454167 (case), Lot Numbers: 23JDB593.

Distribution pattern

US Nationwide distribution.

device · product 18 of 20

MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F

Z-0528-2026
Recall number
Z-0528-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

UDI/DI 10195327454227 (each) 40195327454228 (case), Lot Numbers: 23HDA742

Distribution pattern

US Nationwide distribution.

device · product 19 of 20

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.

Z-0529-2026
Recall number
Z-0529-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
345 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

1) REF DYNJ27466S: UDI/DI 10195327350314 (each) 40195327350315 (case), Lot Numbers: 23EBC912, 23GBA465; 2) REF DYNJ27466T: UDI/DI 10195327463236 (each) 40195327463237 (case), Lot Numbers: 23HBF556, 24ABL037, 24BBI117, 24DBJ229, 24DBK007.

Distribution pattern

US Nationwide distribution.

device · product 20 of 20

MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 8) TOTAL HIP CDS, REF CDS940843AA; 9) TOTAL HIP CDS, REF CDS940963Y; 10) SHOULDER CDS, REF CDS941065L; 11) LAMINECTOMY CDS-LF, REF CDS981923X; 12) TOTAL KNEE CDS, REF CDS982823S; 13) LOWER EXTREMITY CDS, REF CDS982943S; 14) LOWER EXTREMITY CDS, REF CDS982943T; 15) TOTAL KNEE, REF CDS982986U; 16) EXTREMITY CDS, REF CDS983031Q; 17) PODIATRY CDS, REF CDS983610L; 18) TOTAL HIP CDS-LF, REF CDS983761N; 19) BASIC ORTHO CDS, REF CDS983769L; 20) UPPER EXTREMITY CDS, REF CDS983907L; 21) LOWER EXTREMITY CDS, REF CDS983909P; 22) GENERAL ORTHO CDS, REF CDS983915M; 23) MAJOR ORTHO, REF CDS984253L; 24) LOWER EXTREMTIY, REF CDS984254M; 25) TOTAL KNEE, REF CDS985566R; 26) ORTHO PACK, REF DYNJ00284M; 27) CRANIOTOMY PACK-LF, REF DYNJ0160354C; 28) CRANIOTOMY PACK-LF, REF DYNJ0161342C; 29) CRANIOTOMY PACK-LF, REF DYNJ0161342D; 30) CRANIOTOMY HARPER PACK-LF, REF DYNJ0162022G; 31) SPINE PACK-LF, REF DYNJ0376635P; 32) GP-TOTAL JOINT -LF, REF DYNJ0396868V; 33) GP-EXTREMITY/SHOULDER PACK-LF, REF DYNJ0396906P; 34) EXTREMITY PACK-LF, REF DYNJ0519273N; 35) TOTAL KNEE PACK-LF, REF DYNJ0530895AO; 36) TOTAL KNEE PACK-LF, REF DYNJ0530895AP; 37) UPPER EXTREMITY PACK-LF, REF DYNJ0532846S; 38) LOWER EXTREMITY PACK-LF, REF DYNJ0532852Q; 39) ACL SSC PACK-LF, REF DYNJ0536892U; 40) TOTAL HIP PACK-LF, REF DYNJ0536903AL; 41) TOTAL HIP PACK-LF, REF DYNJ0536903AM; 42) LOWER EXTREMITY PACK-LF, REF DYNJ0587115R; 43) TOTAL HIP PACK-LF, REF DYNJ0618354V; 44) TOTAL KNEE PACK-LF, REF DYNJ0646272S; 45) SPINE ANT POST ADD A PACK-LF, REF DYNJ0753208J; 46) OPEN SHOULDER SSC PACK, REF DYNJ0840659T; 47) TOTAL JOINT PACK-LF, REF DYNJ0885263F; 48) TOTAL KNEE PACK, REF DYNJ21813J; 49) CRANIO/MAXILOFACIAL #49-RF, REF DYNJ21826R; 50) TOTAL HIP PACK, REF DYNJ27315K; 51) PODIATRY PACK, REF DYNJ33978K; 52) LOWER EXTREMITY, REF DYNJ34420N; 53) LOWER EXTREMITY, REF DYNJ34420O; 54) GENERAL ORTHO, REF DYNJ34428O; 55) ARTHROSCOPY PACK, REF DYNJ35835G; 56) HAND PACK, REF DYNJ37697J; 57) ACH SPINE PACK, REF DYNJ38042K; 58) SHOULDER ARTHROSCOPY PACK, REF DYNJ38224C; 59) LAMINECTOMY PACK, REF DYNJ38227C; 60) EXTREMITY PACK, REF DYNJ38234G; 61) TOTAL JOINT PACK, REF DYNJ40982D; 62) SPINE PACK, REF DYNJ40995B; 63) EXTREMITY PACK, REF DYNJ41416G; 64) TOTAL JOINT PACK, REF DYNJ42793D; 65) CRANIOTOMY PACK-LF, REF DYNJ43208G; 66) HIP I PACK-LF, REF DYNJ43215I; 67) LAMINECTOMY PACK-LF, REF DYNJ43218G; 68) LIMB PACK-LF, REF DYNJ43220G; 69) SPLIT PACK-LF, REF DYNJ43225G; 70) TOTAL KNEE PACK-LF, REF DYNJ43226I; 71) EXTREMITY PACK, REF DYNJ44681J; 72) SHOULDER PACK, REF DYNJ44685L; 73) TOTAL KNEE PACK, REF DYNJ44687L; 74) UPPER EXTREMITY PACK, REF DYNJ44688I; 75) PODIATRY PACK, REF DYNJ44692G; 76) ACL PACK, REF DYNJ44849F; 77) CENTRACARE PLAZA-MINOR ORTHO, REF DYNJ44860I; 78) MAJOR EXTREMITY, REF DYNJ44878D; 79) ORTHO HIP, REF DYNJ44884G; 80) EXTREMITY PACK, REF DYNJ45332G;

Z-0530-2026
Recall number
Z-0530-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
40151 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Code information

REF CDS780119V: UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 23GBQ904; REF CDS780119V: UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 23JBS979; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 23LBD720; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24BBK043; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24CBA347; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24EBM283; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24GBB624; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23GBS348; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23HBJ325; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24ABK205; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24ABW098; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24BBN591; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24CBS634; REF CDS780208I: UDI/DI 10195327525231 (each) 40195327525232 (case), Lot Numbers: 23JBU709; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 23LBF304; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 24ABB904; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 24CBA311; REF CDS940072Y: UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 23KBU712; REF CDS940072Y: UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 24ABY634; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24ABQ717; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24ABU281; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24CBD739; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24DBP226; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24DBD229; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24EBM262; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24EBV396; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24BBO653; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24BBV236; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24CBS637; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24IBD594; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 23GBJ674; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24ABP205; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24CBD703; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24EBT843; REF CDS981923X: UDI/DI 10195327434298 (each) 40195327434299 (case), Lot Numbers: 23HBB366; REF CDS981923X: UDI/DI 10195327434298 (each) 40195327434299 (case), Lot Numbers: 23HBS882; REF CDS982823S: UDI/DI 10195327674403 (each) 40195327674404 (case), Lot Numbers: 24EBL031; REF CDS982943S: UDI/DI 10195327432393 (each) 40195327432394 (case), Lot Numbers: 23HBA580; REF CDS982943S: UDI/DI 10195327432393 (each) 40195327432394 (case), Lot Numbers: 23HBN648; REF CDS982943T: UDI/DI 10195327627003 (each) 40195327627004 (case), Lot Numbers: 24DBW083; REF CDS982943T: UDI/DI 10195327627003 (each) 40195327627004 (case), Lot Numbers: 24GBC807; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 23LBJ387; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 23LBQ432; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 24ABP570; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 24CBI682; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 24EBC693; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 23IBW098; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24BBB180; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24BBU600; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24CBN838; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24EBT875; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24FBS402; REF CDS983610L: UDI/DI 10195327210151 (each) 40195327210152 (case), Lot Numbers: 23HBC818; REF CDS983610L: UDI/DI 10195327210151 (each) 40195327210152 (case), Lot Numbers: 24DBE385; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23JBC403; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23JBM156; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23JBU065; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23LBD278; REF CDS983769L: UDI/DI 10195327451196 (each) 40195327451197 (case), Lot Numbers: 23HBP622; REF CDS983769L: UDI/DI 10195327451196 (each) 40195327451197 (case), Lot Numbers: 23JBC159; REF CDS983769L: UDI/DI 10195327451196 (each) 40195327451197 (case), Lot Numbers: 23KBP622; REF CDS983907L: UDI/DI 10195327238346 (each) 40195327238347 (case), Lot Numbers: 23IBC640; REF CDS983907L: UDI/DI 10195327238346 (each) 40195327238347 (case), Lot Numbers: 23LBM312; REF CDS983909P: UDI/DI 10195327238384 (each) 40195327238385 (case), Lot Numbers: 23IBW039; REF CDS983909P: UDI/DI 10195327238384 (each) 40195327238385 (case), Lot Numbers: 23JBB094; REF CDS983909P: UDI/DI 10195327238384 (each) 40195327238385 (case), Lot Numbers: 23LBK752; REF CDS983915M: UDI/DI 10195327238353 (each) 40195327238354 (case), Lot Numbers: 24ABG846; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24ABD711; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24ABP282; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24BBI150; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24CBS643; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24DBK828; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24EBP547; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 23HBD301; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24ABT691; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24BBS781; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24DBS099; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24EBF862; REF CDS985566R: UDI/DI 10198459014758 (each) 40198459014759 (case), Lot Numbers: 24GBH839; REF DYNJ00284M: UDI/DI 10195327412036 (each) 40195327412037 (case), Lot Numbers: 23GMA018; REF DYNJ00284M: UDI/DI 10195327412036 (each) 40195327412037 (case), Lot Numbers: 24AMC690; REF DYNJ0160354C: UDI/DI 10195327320072 (each) 40195327320073 (case), Lot Numbers: 23GDA315; REF DYNJ0160354C: UDI/DI 10195327320072 (each) 40195327320073 (case), Lot Numbers: 23GDB867; REF DYNJ0161342C: UDI/DI 10195327357269 (each) 40195327357260 (case), Lot Numbers: 23EDA760; REF DYNJ0161342D: UDI/DI 10195327478506 (each) 40195327478507 (case), Lot Numbers: 23HDB481; REF DYNJ0162022G: UDI/DI 10195327404598 (each) 40195327404599 (case), Lot Numbers: 23FDB286; REF DYNJ0162022G: UDI/DI 10195327404598 (each) 40195327404599 (case), Lot Numbers: 23GDA631; REF DYNJ0162022G: UDI/DI 10195327404598 (each) 40195327404599 (case), Lot Numbers: 23HDA239; REF DYNJ0376635P: UDI/DI 10195327532987 (each) 40195327532988 (case), Lot Numbers: 24AMB890; REF DYNJ0396868V: UDI/DI 10195327454258 (each) 40195327454259 (case), Lot Numbers: 23GDB690; REF DYNJ0396906P: UDI/DI 10195327454197 (each) 40195327454198 (case), Lot Numbers: 23HDB063; REF DYNJ0396906P: UDI/DI 10195327454197 (each) 40195327454198 (case), Lot Numbers: 23JDB511; REF DYNJ0519273N: UDI/DI 10195327083472 (each) 40195327083473 (case), Lot Numbers: 23EMA335; REF DYNJ0530895AO: UDI/DI 10193489782790 (each) 40193489782791 (case), Lot Numbers: 24ABS237; REF DYNJ0530895AP: UDI/DI 10195327628550 (each) 40195327628551 (case), Lot Numbers: 24CBJ626; REF DYNJ0530895AP: UDI/DI 10195327628550 (each) 40195327628551 (case), Lot Numbers: 24DBH846; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 23JME365; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 23KMF703; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 23KMJ025; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 24AMI561; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 23JMC960; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 23LMA587; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 24BMJ693; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 24BMJ826; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 24DMK245; REF DYNJ0536892U: UDI/DI 10195327206239 (each) 40195327206230 (case), Lot Numbers: 23HBH153; REF DYNJ0536892U: UDI/DI 10195327206239 (each) 40195327206230 (case), Lot Numbers: 24DBH427; REF DYNJ0536892U: UDI/DI 10195327206239 (each) 40195327206230 (case), Lot Numbers: 24DBI493; REF DYNJ0536903AL: UDI/DI 10193489782783 (each) 40193489782784 (case), Lot Numbers: 24ABK586; REF DYNJ0536903AM: UDI/DI 10195327628567 (each) 40195327628568 (case), Lot Numbers: 24DBA383; REF DYNJ0536903AM: UDI/DI 10195327628567 (each) 40195327628568 (case), Lot Numbers: 24JBS809; REF DYNJ0587115R: UDI/DI 10195327561888 (each) 40195327561889 (case), Lot Numbers: 24BBP114; REF DYNJ0587115R: UDI/DI 10195327561888 (each) 40195327561889 (case), Lot Numbers: 24DBO138; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 23GBG269; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 23GMC905; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 24ABH235; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 24CBR569; REF DYNJ0646272S: UDI/DI 10889942860920 (each) 40889942860921 (case), Lot Numbers: 23KBU390; REF DYNJ0646272S: UDI/DI 10889942860920 (each) 40889942860921 (case), Lot Numbers: 24CBU458; REF DYNJ0753208J: UDI/DI 10195327689896 (each) 40195327689897 (case), Lot Numbers: 24FME095; REF DYNJ0840659T: UDI/DI 10195327206512 (each) 40195327206513 (case), Lot Numbers: 23LBS322; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 23JMG075; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 23KMI286; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 24AMH655; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 24CMC882; REF DYNJ21813J: UDI/DI 10195327515867 (each) 40195327515868 (case), Lot Numbers: 23JBE704; REF DYNJ21813J: UDI/DI 10195327515867 (each) 40195327515868 (case), Lot Numbers: 24ABV081; REF DYNJ21826R: UDI/DI 10195327104412 (each) 40195327104413 (case), Lot Numbers: 23LBA701; REF DYNJ27315K: UDI/DI 10195327515966 (each) 40195327515967 (case), Lot Numbers: 23KBC303; REF DYNJ33978K: UDI/DI 10195327436315 (each) 40195327436316 (case), Lot Numbers: 23GBR447; REF DYNJ33978K: UDI/DI 10195327436315 (each) 40195327436316 (case), Lot Numbers: 23IBR613; REF DYNJ34420N: UDI/DI 10195327384388 (each) 40195327384389 (case), Lot Numbers: 23GBI363; REF DYNJ34420N: UDI/DI 10195327384388 (each) 40195327384389 (case), Lot Numbers: 23IBG432; REF DYNJ34420N: UDI/DI 10195327384388 (each) 40195327384389 (case), Lot Numbers: 23IBR127; REF DYNJ34420N: UDI/DI 10195327384388 (each) 40195327384389 (case), Lot Numbers: 23LBN020; REF DYNJ34420O: UDI/DI 10195327610616 (each) 40195327610617 (case), Lot Numbers: 24ABN426; REF DYNJ34420O: UDI/DI 10195327610616 (each) 40195327610617 (case), Lot Numbers: 24BBV753; REF DYNJ34420O: UDI/DI 10195327610616 (each) 40195327610617 (case), Lot Numbers: 24DBA214; REF DYNJ34420O: UDI/DI 10195327610616 (each) 40195327610617 (case), Lot Numbers: 24DBJ230; REF DYNJ34428O: UDI/DI 10195327384333 (each) 40195327384334 (case), Lot Numbers: 23KMF246; REF DYNJ34428O: UDI/DI 10195327384333 (each) 40195327384334 (case), Lot Numbers: 24AMI130; REF DYNJ34428O: UDI/DI 10195327384333 (each) 40195327384334 (case), Lot Numbers: 24DMF181; REF DYNJ35835G: UDI/DI 10195327412005 (each) 40195327412006 (case), Lot Numbers: 23GMI346; REF DYNJ35835G: UDI/DI 10195327412005 (each) 40195327412006 (case), Lot Numbers: 23IMF703; REF DYNJ37697J: UDI/DI 10195327448325 (each) 40195327448326 (case), Lot Numbers: 23JME360; REF DYNJ37697J: UDI/DI 10195327448325 (each) 40195327448326 (case), Lot Numbers: 23LMF291; REF DYNJ37697J: UDI/DI 10195327448325 (each) 40195327448326 (case), Lot Numbers: 24BME117; REF DYNJ37697J: UDI/DI 10195327448325 (each) 40195327448326 (case), Lot Numbers: 24EMF837; REF DYNJ38042K: UDI/DI 10195327416539 (each) 40195327416530 (case), Lot Numbers: 23GBC482; REF DYNJ38042K: UDI/DI 10195327416539 (each) 40195327416530 (case), Lot Numbers: 23HBU981; REF DYNJ38042K: UDI/DI 10195327416539 (each) 40195327416530 (case), Lot Numbers: 23KBF956; REF DYNJ38224C: UDI/DI 10195327381479 (each) 40195327381470 (case), Lot Numbers: 23DBJ365; REF DYNJ38224C: UDI/DI 10195327381479 (each) 40195327381470 (case), Lot Numbers: 23GBO385; REF DYNJ38224C: UDI/DI 10195327381479 (each) 40195327381470 (case), Lot Numbers: 23GBU542; REF DYNJ38224C: UDI/DI 10195327381479 (each) 40195327381470 (case), Lot Numbers: 23HBL905; REF DYNJ38227C: UDI/DI 10195327381486 (each) 40195327381487 (case), Lot Numbers: 23KBG323; REF DYNJ38234G: UDI/DI 10195327327651 (each) 40195327327652 (case), Lot Numbers: 23DBJ638; REF DYNJ38234G: UDI/DI 10195327327651 (each) 40195327327652 (case), Lot Numbers: 23EBR720; REF DYNJ40982D: UDI/DI 10889942564002 (each) 40889942564003 (case), Lot Numbers: 24ABA449; REF DYNJ40982D: UDI/DI 10889942564002 (each) 40889942564003 (case), Lot Numbers: 24BBG971; REF DYNJ40995B: UDI/DI 10889942431236 (each) 40889942431237 (case), Lot Numbers: 24BBS824; REF DYNJ41416G: UDI/DI 10195327220976 (each) 40195327220977 (case), Lot Numbers: 23GBA790; REF DYNJ41416G: UDI/DI 10195327220976 (each) 40195327220977 (case), Lot Numbers: 23HBE316; REF DYNJ42793D: UDI/DI 10193489427547 (each) 40193489427548 (case), Lot Numbers: 23IME206; REF DYNJ43208G: UDI/DI 10193489953053 (each) 40193489953054 (case), Lot Numbers: 23DMG563; REF DYNJ43208G: UDI/DI 10193489953053 (each) 40193489953054 (case), Lot Numbers: 23EME340; REF DYNJ43215I: UDI/DI 10193489953084 (each) 40193489953085 (case), Lot Numbers: 23JMA398; REF DYNJ43218G: UDI/DI 10195327421977 (each) 40195327421978 (case), Lot Numbers: 23HMC253; REF DYNJ43220G: UDI/DI 10193489953114 (each) 40193489953115 (case), Lot Numbers: 23GME630; REF DYNJ43225G: UDI/DI 10193489958874 (each) 40193489958875 (case), Lot Numbers: 23EMA404; REF DYNJ43226I: UDI/DI 10193489953039 (each) 40193489953030 (case), Lot Numbers: 23GMC914; REF DYNJ43226I: UDI/DI 10193489953039 (each) 40193489953030 (case), Lot Numbers: 23IME870; REF DYNJ43226I: UDI/DI 10193489953039 (each) 40193489953030 (case), Lot Numbers: 23IMF935; REF DYNJ44681J: UDI/DI 10195327130886 (each) 40195327130887 (case), Lot Numbers: 23EDA416; REF DYNJ44685L: UDI/DI 10195327127404 (each) 40195327127405 (case), Lot Numbers: 23EBT781; REF DYNJ44687L: UDI/DI 10195327127411 (each) 40195327127412 (case), Lot Numbers: 23JMA252; REF DYNJ44688I: UDI/DI 10195327127374 (each) 40195327127375 (case), Lot Numbers: 23HBA230; REF DYNJ44688I: UDI/DI 10195327127374 (each) 40195327127375 (case), Lot Numbers: 23JBJ203; REF DYNJ44692G: UDI/DI 10195327277574 (each) 40195327277575 (case), Lot Numbers: 23EDA887; REF DYNJ44692G: UDI/DI 10195327277574 (each) 40195327277575 (case), Lot Numbers: 23FDB510; REF DYNJ44692G: UDI/DI 10195327277574 (each) 40195327277575 (case), Lot Numbers: 23JDB517; REF DYNJ44849F: UDI/DI 10195327127572 (each) 40195327127573 (case), Lot Numbers: 23EDA066; REF DYNJ44849F: UDI/DI 10195327127572 (each) 40195327127573 (case), Lot Numbers: 23GDA271; REF DYNJ44849F: UDI/DI 10195327127572 (each) 40195327127573 (case), Lot Numbers: 23GDC025; REF DYNJ44860I: UDI/DI 10195327127343 (each) 40195327127344 (case), Lot Numbers: 23HDB166; REF DYNJ44878D: UDI/DI 10195327127701 (each) 40195327127702 (case), Lot Numbers: 23EDB339; REF DYNJ44878D: UDI/DI 10195327127701 (each) 40195327127702 (case), Lot Numbers: 23GDB902; REF DYNJ44884G: UDI/DI 10195327298425 (each) 40195327298426 (case), Lot Numbers: 23EDB345; REF DYNJ44884G: UDI/DI 10195327298425 (each) 40195327298426 (case), Lot Numbers: 23FDB539; REF DYNJ45332G: UDI/DI 10195327242534 (each) 40195327242535 (case), Lot Numbers: 23GMI355; REF DYNJ46676F: UDI/DI 10193489887617 (each) 40193489887618 (case), Lot Numbers: 23JDB444; REF DYNJ46676F: UDI/DI 10193489887617 (each) 40193489887618 (case), Lot Numbers: 23JDB935; REF DYNJ46676F: UDI/DI 10193489887617 (each) 40193489887618 (case), Lot Numbers: 23KDA590; REF DYNJ46676F: UDI/DI 10193489887617 (each) 40193489887618 (case), Lot Numbers: 24ADA920; REF DYNJ46698G: UDI/DI 10195327224066 (each) 40195327224067 (case), Lot Numbers: 23DDB946; REF DYNJ46698G: UDI/DI 10195327224066 (each) 40195327224067 (case), Lot Numbers: 23FDA276; REF DYNJ46698G: UDI/DI 10195327224066 (each) 40195327224067 (case), Lot Numbers: 23GDA719; REF DYNJ46931D: UDI/DI 10195327515638 (each) 40195327515639 (case), Lot Numbers: 23JBJ349; REF DYNJ47698P: UDI/DI 10195327437084 (each) 40195327437085 (case), Lot Numbers: 23GME940; REF DYNJ47698Q: UDI/DI 10195327509422 (each) 40195327509423 (case), Lot Numbers: 23JMC147; REF DYNJ47698Q: UDI/DI 10195327509422 (each) 40195327509423 (case), Lot Numbers: 23JME063; REF DYNJ47698Q: UDI/DI 10195327509422 (each) 40195327509423 (case), Lot Numbers: 23KMG557; REF DYNJ47698Q: UDI/DI 10195327509422 (each) 40195327509423 (case), Lot Numbers: 23LMH560; REF DYNJ47698Q: UDI/DI 10195327509422 (each) 40195327509423 (case), Lot Numbers: 24BME277; REF DYNJ47701K: UDI/DI 10195327509118 (each) 40195327509119 (case), Lot Numbers: 23IBU539; REF DYNJ47701K: UDI/DI 10195327509118 (each) 40195327509119 (case), Lot Numbers: 23LBE644; REF DYNJ47701K: UDI/DI 10195327509118 (each) 40195327509119 (case), Lot Numbers: 24CBE391; REF DYNJ47701K: UDI/DI 10195327509118 (each) 40195327509119 (case), Lot Numbers: 24DBU536; REF DYNJ48090I: UDI/DI 10195327500115 (each) 40195327500116 (case), Lot Numbers: 23LMC258; REF DYNJ48090I: UDI/DI 10195327500115 (each) 40195327500116 (case), Lot Numbers: 25BMA374; REF DYNJ48091I: UDI/DI 10195327500122 (each) 40195327500123 (case), Lot Numbers: 23IMG184; REF DYNJ48091I: UDI/DI 10195327500122 (each) 40195327500123 (case), Lot Numbers: 24DMG049; REF DYNJ48130K: UDI/DI 10195327349448 (each) 40195327349449 (case), Lot Numbers: 23FBQ393; REF DYNJ48130K: UDI/DI 10195327349448 (each) 40195327349449 (case), Lot Numbers: 24BBL782; REF DYNJ50127D: UDI/DI 10195327212186 (each) 40195327212187 (case), Lot Numbers: 23JBD975; REF DYNJ50621K: UDI/DI 10195327002756 (each) 40195327002757 (case), Lot Numbers: 23GMI091; REF DYNJ50621L: UDI/DI 10195327501174 (each) 40195327501175 (case), Lot Numbers: 23IMH003; REF DYNJ50621L: UDI/DI 10195327501174 (each) 40195327501175 (case), Lot Numbers: 23KMB960; REF DYNJ50621L: UDI/DI 10195327501174 (each) 40195327501175 (case), Lot Numbers: 23LMF863; REF DYNJ50622K: UDI/DI 10195327501198 (each) 40195327501199 (case), Lot Numbers: 23KMF214; REF DYNJ50622K: UDI/DI 10195327501198 (each) 40195327501199 (case), Lot Numbers: 24AMD236; REF DYNJ50622K: UDI/DI 10195327501198 (each) 40195327501199 (case), Lot Numbers: 24BME594; REF DYNJ51567G: UDI/DI 10195327430153 (each) 40195327430154 (case), Lot Numbers: 23KBR665; REF DYNJ51567G: UDI/DI 10195327430153 (each) 40195327430154 (case), Lot Numbers: 24CBL506; REF DYNJ51567G: UDI/DI 10195327430153 (each) 40195327430154 (case), Lot Numbers: 24DBU743; REF DYNJ51567G: UDI/DI 10195327430153 (each) 40195327430154 (case), Lot Numbers: 24EBL973; REF DYNJ52007C: UDI/DI 10889942796878 (each) 40889942796879 (case), Lot Numbers: 23GMD252; REF DYNJ52007F: UDI/DI 10195327563141 (each) 40195327563142 (case), Lot Numbers: 23LBE651; REF DYNJ52007F: UDI/DI 10195327563141 (each) 40195327563142 (case), Lot Numbers: 24DBB359; REF DYNJ52007F: UDI/DI 10195327563141 (each) 40195327563142 (case), Lot Numbers: 24DBO178; REF DYNJ52331F: UDI/DI 10195327237691 (each) 40195327237692 (case), Lot Numbers: 24ABQ379; REF DYNJ52332G: UDI/DI 10195327237707 (each) 40195327237708 (case), Lot Numbers: 23EBQ263; REF DYNJ52332I: UDI/DI 10195327447731 (each) 40195327447732 (case), Lot Numbers: 23FBV979; REF DYNJ52332I: UDI/DI 10195327447731 (each) 40195327447732 (case), Lot Numbers: 23KBI476; REF DYNJ52332I: UDI/DI 10195327447731 (each) 40195327447732 (case), Lot Numbers: 24ABS792; REF DYNJ52333F: UDI/DI 10195327434083 (each) 40195327434084 (case), Lot Numbers: 23HBE931; REF DYNJ52333F: UDI/DI 10195327434083 (each) 40195327434084 (case), Lot Numbers: 23JBB688; REF DYNJ52333F: UDI/DI 10195327434083 (each) 40195327434084 (case), Lot Numbers: 24ABO902; REF DYNJ53006C: UDI/DI 10193489782745 (each) 40193489782746 (case), Lot Numbers: 23HMC677; REF DYNJ53006C: UDI/DI 10193489782745 (each) 40193489782746 (case), Lot Numbers: 23JMA848; REF DYNJ53006C: UDI/DI 10193489782745 (each) 40193489782746 (case), Lot Numbers: 23LMA051; REF DYNJ53006D: UDI/DI 10195327628390 (each) 40195327628391 (case), Lot Numbers: 24CBP971; REF DYNJ53555F: UDI/DI 10195327410056 (each) 40195327410057 (case), Lot Numbers: 24ABR006; REF DYNJ53555F: UDI/DI 10195327410056 (each) 40195327410057 (case), Lot Numbers: 24DBK404; REF DYNJ53555F: UDI/DI 10195327410056 (each) 40195327410057 (case), Lot Numbers: 24EBA656; REF DYNJ55852C: UDI/DI 10195327267575 (each) 40195327267576 (case), Lot Numbers: 23GMF007; REF DYNJ55852C: UDI/DI 10195327267575 (each) 40195327267576 (case), Lot Numbers: 24CMI123; REF DYNJ57648D: UDI/DI 10195327027391 (each) 40195327027392 (case), Lot Numbers: 23IMG853; REF DYNJ57648D: UDI/DI 10195327027391 (each) 40195327027392 (case), Lot Numbers: 23KMH101; REF DYNJ57648D: UDI/DI 10195327027391 (each) 40195327027392 (case), Lot Numbers: 23LME559; REF DYNJ57648F: UDI/DI 10195327610357 (each) 40195327610358 (case), Lot Numbers: 24BME622; REF DYNJ58557C: UDI/DI 10193489972276 (each) 40193489972277 (case), Lot Numbers: 23KMF224; REF DYNJ58557C: UDI/DI 10193489972276 (each) 40193489972277 (case), Lot Numbers: 23LMG741; REF DYNJ58557D: UDI/DI 10195327615192 (each) 40195327615193 (case), Lot Numbers: 24BME252; REF DYNJ58563D: UDI/DI 10193489972320 (each) 40193489972321 (case), Lot Numbers: 23IMG567; REF DYNJ58564D: UDI/DI 10193489972337 (each) 40193489972338 (case), Lot Numbers: 23KMD387; REF DYNJ58665F: UDI/DI 10195327529741 (each) 40195327529742 (case), Lot Numbers: 23KMH652; REF DYNJ58665F: UDI/DI 10195327529741 (each) 40195327529742 (case), Lot Numbers: 23LMB459; REF DYNJ58665F: UDI/DI 10195327529741 (each) 40195327529742 (case), Lot Numbers: 24CME058; REF DYNJ58665F: UDI/DI 10195327529741 (each) 40195327529742 (case), Lot Numbers: 24DMG301; REF DYNJ59819A: UDI/DI 10195327331597 (each) 40195327331598 (case), Lot Numbers: 23GBF959; REF DYNJ59819A: UDI/DI 10195327331597 (each) 40195327331598 (case), Lot Numbers: 23LBD961; REF DYNJ60049B: UDI/DI 10193489782776 (each) 40193489782777 (case), Lot Numbers: 23HBH184; REF DYNJ60049C: UDI/DI 10195327628413 (each) 40195327628414 (case), Lot Numbers: 24BBU890; REF DYNJ60049C: UDI/DI 10195327628413 (each) 40195327628414 (case), Lot Numbers: 24DBS448; REF DYNJ60194C: UDI/DI 10195327529765 (each) 40195327529766 (case), Lot Numbers: 23LMA120; REF DYNJ60495I: UDI/DI 10195327599645 (each) 40195327599646 (case), Lot Numbers: 24ABB590; REF DYNJ60550B: UDI/DI 10195327361853 (each) 40195327361854 (case), Lot Numbers: 23EBB225; REF DYNJ60550B: UDI/DI 10195327361853 (each) 40195327361854 (case), Lot Numbers: 23EBM228; REF DYNJ60550B: UDI/DI 10195327361853 (each) 40195327361854 (case), Lot Numbers: 23GBW407; REF DYNJ60550B: UDI/DI 10195327361853 (each) 40195327361854 (case), Lot Numbers: 23JBC621; REF DYNJ60550B: UDI/DI 10195327361853 (each) 40195327361854 (case), Lot Numbers: 24ABM138; REF DYNJ60553B: UDI/DI 10195327361822 (each) 40195327361823 (case), Lot Numbers: 23FBD830; REF DYNJ60553B: UDI/DI 10195327361822 (each) 40195327361823 (case), Lot Numbers: 23GBV207; REF DYNJ60553B: UDI/DI 10195327361822 (each) 40195327361823 (case), Lot Numbers: 23HBX302; REF DYNJ60553B: UDI/DI 10195327361822 (each) 40195327361823 (case), Lot Numbers: 23JBJ796; REF DYNJ61340B: UDI/DI 10195327401092 (each) 40195327401093 (case), Lot Numbers: 23EBI869; REF DYNJ61414C: UDI/DI 10195327401016 (each) 40195327401017 (case), Lot Numbers: 23EBI870; REF DYNJ61651J: UDI/DI 10195327388447 (each) 40195327388448 (case), Lot Numbers: 23IMF466; REF DYNJ61651J: UDI/DI 10195327388447 (each) 40195327388448 (case), Lot Numbers: 23JMB216; REF DYNJ61651J: UDI/DI 10195327388447 (each) 40195327388448 (case), Lot Numbers: 23KMI579; REF DYNJ61651J: UDI/DI 10195327388447 (each) 40195327388448 (case), Lot Numbers: 23LMH297; REF DYNJ61651J: UDI/DI 10195327388447 (each) 40195327388448 (case), Lot Numbers: 24CMJ082; REF DYNJ61663A: UDI/DI 10193489929652 (each) 40193489929653 (case), Lot Numbers: 23EBI830; REF DYNJ61663A: UDI/DI 10193489929652 (each) 40193489929653 (case), Lot Numbers: 23IBD773; REF DYNJ61663A: UDI/DI 10193489929652 (each) 40193489929653 (case), Lot Numbers: 23IBS880; REF DYNJ62612D: UDI/DI 10195327528089 (each) 40195327528080 (case), Lot Numbers: 23LMG302; REF DYNJ62612D: UDI/DI 10195327528089 (each) 40195327528080 (case), Lot Numbers: 24BME477; REF DYNJ62612D: UDI/DI 10195327528089 (each) 40195327528080 (case), Lot Numbers: 24CMD895; REF DYNJ62612D: UDI/DI 10195327528089 (each) 40195327528080 (case), Lot Numbers: 24DMD795; REF DYNJ62650B: UDI/DI 10195327121846 (each) 40195327121847 (case), Lot Numbers: 23LBJ206; REF DYNJ62650B: UDI/DI 10195327121846 (each) 40195327121847 (case), Lot Numbers: 24ABU953; REF DYNJ62650B: UDI/DI 10195327121846 (each) 40195327121847 (case), Lot Numbers: 24DBG292; REF DYNJ62650B: UDI/DI 10195327121846 (each) 40195327121847 (case), Lot Numbers: 24DBO663; REF DYNJ63082C: UDI/DI 10195327505615 (each) 40195327505616 (case), Lot Numbers: 23KMC330; REF DYNJ63082C: UDI/DI 10195327505615 (each) 40195327505616 (case), Lot Numbers: 23KMH957; REF DYNJ63082C: UDI/DI 10195327505615 (each) 40195327505616 (case), Lot Numbers: 23LMG702; REF DYNJ63473C: UDI/DI 10195327510923 (each) 40195327510924 (case), Lot Numbers: 23IMF358; REF DYNJ63473C: UDI/DI 10195327510923 (each) 40195327510924 (case), Lot Numbers: 24BMA722; REF DYNJ63559B: UDI/DI 10193489900422 (each) 40193489900423 (case), Lot Numbers: 24ABV064; REF DYNJ64233C: UDI/DI 10195327452957 (each) 40195327452958 (case), Lot Numbers: 23HME045; REF DYNJ64233C: UDI/DI 10195327452957 (each) 40195327452958 (case), Lot Numbers: 23IMI013; REF DYNJ64240A: UDI/DI 10193489382631 (each) 40193489382632 (case), Lot Numbers: 23DMF071; REF DYNJ64276C: UDI/DI 10195327091095 (each) 40195327091096 (case), Lot Numbers: 23HBN381; REF DYNJ64276C: UDI/DI 10195327091095 (each) 40195327091096 (case), Lot Numbers: 23LBB663; REF DYNJ64276C: UDI/DI 10195327091095 (each) 40195327091096 (case), Lot Numbers: 24ABT845; REF DYNJ64276C: UDI/DI 10195327091095 (each) 40195327091096 (case), Lot Numbers: 24DBB304; REF DYNJ64672B: UDI/DI 10195327377496 (each) 40195327377497 (case), Lot Numbers: 23KMJ289; REF DYNJ64672B: UDI/DI 10195327377496 (each) 40195327377497 (case), Lot Numbers: 23LMD300; REF DYNJ64981F: UDI/DI 10195327528133 (each) 40195327528134 (case), Lot Numbers: 23KMA711; REF DYNJ64981F: UDI/DI 10195327528133 (each) 40195327528134 (case), Lot Numbers: 24AMI362; REF DYNJ64981F: UDI/DI 10195327528133 (each) 40195327528134 (case), Lot Numbers: 24DMH548; REF DYNJ65036C: UDI/DI 10195327528225 (each) 40195327528226 (case), Lot Numbers: 23KMJ862; REF DYNJ65036C: UDI/DI 10195327528225 (each) 40195327528226 (case), Lot Numbers: 24AMI363; REF DYNJ65036C: UDI/DI 10195327528225 (each) 40195327528226 (case), Lot Numbers: 24CMF696; REF DYNJ65037B: UDI/DI 10195327528232 (each) 40195327528233 (case), Lot Numbers: 23JMF193; REF DYNJ65037B: UDI/DI 10195327528232 (each) 40195327528233 (case), Lot Numbers: 24AMA504; REF DYNJ65037B: UDI/DI 10195327528232 (each) 40195327528233 (case), Lot Numbers: 24BMD982; REF DYNJ65178G: UDI/DI 10195327528270 (each) 40195327528271 (case), Lot Numbers: 23KMG308; REF DYNJ65178G: UDI/DI 10195327528270 (each) 40195327528271 (case), Lot Numbers: 23LMG257; REF DYNJ65178G: UDI/DI 10195327528270 (each) 40195327528271 (case), Lot Numbers: 24CMC043; REF DYNJ65178G: UDI/DI 10195327528270 (each) 40195327528271 (case), Lot Numbers: 24DMD461; REF DYNJ65240B: UDI/DI 10195327163778 (each) 40195327163779 (case), Lot Numbers: 24DBE167; REF DYNJ65358B: UDI/DI 10195327415037 (each) 40195327415038 (case), Lot Numbers: 23HMC318; REF DYNJ65359A: UDI/DI 10195327415020 (each) 40195327415021 (case), Lot Numbers: 23HMC429; REF DYNJ65378A: UDI/DI 10195327418076 (each) 40195327418077 (case), Lot Numbers: 23HMA809; REF DYNJ65381A: UDI/DI 10195327418090 (each) 40195327418091 (case), Lot Numbers: 23KMC819; REF DYNJ65384A: UDI/DI 10195327410070 (each) 40195327410071 (case), Lot Numbers: 23EMC378; REF DYNJ65386C: UDI/DI 10195327410087 (each) 40195327410088 (case), Lot Numbers: 23FMC511; REF DYNJ65386C: UDI/DI 10195327410087 (each) 40195327410088 (case), Lot Numbers: 23HMF637; REF DYNJ65386C: UDI/DI 10195327410087 (each) 40195327410088 (case), Lot Numbers: 24AMB920; REF DYNJ65388B: UDI/DI 10195327418106 (each) 40195327418107 (case), Lot Numbers: 23FMB854; REF DYNJ65388B: UDI/DI 10195327418106 (each) 40195327418107 (case), Lot Numbers: 23GMA062; REF DYNJ65388B: UDI/DI 10195327418106 (each) 40195327418107 (case), Lot Numbers: 23GMI628; REF DYNJ65726D: UDI/DI 10195327528263 (each) 40195327528264 (case), Lot Numbers: 23LBU922; REF DYNJ65726D: UDI/DI 10195327528263 (each) 40195327528264 (case), Lot Numbers: 24ABH394; REF DYNJ65726D: UDI/DI 10195327528263 (each) 40195327528264 (case), Lot Numbers: 24FMH618; REF DYNJ65855B: UDI/DI 10195327232146 (each) 40195327232147 (case), Lot Numbers: 23EBO883; REF DYNJ65855B: UDI/DI 10195327232146 (each) 40195327232147 (case), Lot Numbers: 23GBM189; REF DYNJ65855B: UDI/DI 10195327232146 (each) 40195327232147 (case), Lot Numbers: 23KBB910; REF DYNJ66357C: UDI/DI 10195327227975 (each) 40195327227976 (case), Lot Numbers: 23DBI896; REF DYNJ66357C: UDI/DI 10195327227975 (each) 40195327227976 (case), Lot Numbers: 23EBI969; REF DYNJ67195C: UDI/DI 10195327299705 (each) 40195327299706 (case), Lot Numbers: 23EBQ378; REF DYNJ67195C: UDI/DI 10195327299705 (each) 40195327299706 (case), Lot Numbers: 23IBR151; REF DYNJ67196B: UDI/DI 10195327299712 (each) 40195327299713 (case), Lot Numbers: 23DBJ727; REF DYNJ67196B: UDI/DI 10195327299712 (each) 40195327299713 (case),

Distribution pattern

US Nationwide distribution.