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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97882

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

Open FDA event record

Event summary

Timeline bucket
October 10, 2025
Product types
Device
Classifications
Class I
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

10 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 10

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601; ANESTHESIA CIRCUIT - LF DYNJAA10261B; ANESTHESIA CIRCUIT 120EXP-LF DYNJAA10741A; ANESTHESIA CIRCUIT ADULT-LF DYNJAA0380A DYNJAA10641 DYNJAA10706B DYNJAA10851 DYNJAA10922B DYNJAA10971A DYNJAA11030A DYNJAA11087 DYNJAA11126; ANESTHESIA CIRCUIT-LF DYNJAA0309A DYNJAA0368A DYNJAA10368A DYNJAA10392 DYNJAA10430A DYNJAA10547A DYNJAA10639A DYNJAA10656A DYNJAA10685A DYNJAA10685B; CIRC 120" EXP 1 BV HMEF 3L GSL DYNJAA10920; EXPANDABLE CIRCUIT-LF DYNJAA11095; NM ANESTHESIA TURNOVER KIT DYNJAA0433; PROV HEALTH HEPA CIRC #2-LF DYNJAA0360; SPTMPX01IA CIRCUIT ADULT-LF DYNJAA10973A;

Z-0442-2026
Recall number
Z-0442-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

DYNJAA0309A UDI-DI 40193489400268 (case), 10193489400267 (ea) Lots 25EBU353 25GBI473; DYNJAA0360 UDI DI 40193489419000 (case), 10193489419009 (ea) Lots 25EBU304 25GBQ732; DYNJAA0368A UDI-DI 40195327092550 (case), 10195327092559 (ea) Lots 25GBH582; DYNJAA0380A UDI-DI 40195327478286 (case), 10195327478285 (ea) Lots 25FBB950 25FBT875 25GBX623; DYNJAA0433 UDI-DI 40198459320706 (case), 10198459320705 (ea) Lots 25EBH621 25EBQ391; DYNJAA10261B UDI- DI 40193489430784 (case), 10193489430783 (ea) Lots 25FBJ760; DYNJAA10368A UDI-DI 40198459320720 (case), 10198459320729 (ea) Lots 25GBY374 25IBK072; DYNJAA10392 UDI-DI 40888277962201 (case), 10888277962200 (ea) Lots 25FBN032; DYNJAA10430A UDI-DI 40193489832052 (case), 10193489832051 (ea) Lots 25FBW335 25IBH048; DYNJAA10547A UDI-DI 40193489603188 (case), 10193489603187 (ea) 25FBT853; DYNJAA10591 UDI-DI 40889942632535 (case), 10889942632534 (ea) Lots 25FBD876 25FBD877 25GBJ254 25GBJ256; DYNJAA10601 UDI-DI 40889942655435 (case), 10889942655434 (ea) Lots 25FBN184 25HBM893; DYNJAA10639A UDI-DI 40888277761958 (case), 10888277761957 (ea) Lots 25FBN043; DYNJAA10641 UDI-DI 40889942841227 (case), 10889942841226 (ea) Lots 25EBK360; DYNJAA10656A UDI-DI 40193489455527 (case), 10193489455526 (ea) Lots 25FBN055; DYNJAA10685A UDI-DI 40195327279142 (case), 10195327279141 (ea) Lots 25EBJ456; DYNJAA10685B UDI-DI 40198459372293 (case), 10198459372292 (ea) Lots 25FBL121 25FBT898 25FBT899; DYNJAA10706B UDI-DI 40193489485982 (case), 10193489485981 (ea) Lots 25FBH921 25GBK879 25GBN124 25GBN125; DYNJAA10741A UDI-DI 40193489250573 (case), 10193489250572 (ea) Lots 25EBK364 25FBQ326 25HBA472; DYNJAA10775 UDI-DI 40193489348102 (case), 10193489348101 (ea) Lots 25GBY311 25IBD803; DYNJAA10817 UDI-DI 40193489365338 (case), 10193489365337 (ea) Lots 25GBO619; DYNJAA10851 UDI-DI 40193489429467 (case), 10193489429466 (ea) Lots 25GBE789 25IBL075; DYNJAA10920 UDI-DI 40193489463386 (case), 10193489463385 (ea) Lots 25FBT844 25GBP694; DYNJAA10922B UDI-DI 40198459301880 (case), 10198459301889 (ea) Lots 25FBQ442 25GBO675; DYNJAA10971A UDI-DI 40195327298167 (case), 10195327298166 (ea) Lots 25GBA751; DYNJAA10973A UDI-DI 40195327372423 (case), 10195327372422 (ea) Lots 25FBQ349; DYNJAA11030A UDI-DI 40195327341030 (case), 10195327341039 (ea) Lots 25FBQ346; DYNJAA11087 UDI-DI 40195327694402 (case), 10195327694401 (ea) Lots 25FBG942 25FBG944; DYNJAA11095 UDI-DI 40195327520992 (case), 10195327520991 (ea) Lots 25GBY361; DYNJAA11126 UDI-DI 40195327695508 (case), 10195327695507 (ea) Lots 25EBV629 25GBL211; DYNJAA6555G UDI-DI 40195327214648 (case), 10195327214647 (ea) Lots 25EBG518 25FBS747 25FBS748 25HBE691

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 2 of 10

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550

Z-0443-2026
Recall number
Z-0443-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

DYNJ10550 UDI-DI 40889942469704 (case), 10889942469703 (ea) Lot 25EBQ445

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 3 of 10

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F

Z-0444-2026
Recall number
Z-0444-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

DYNJ909116D UDI-DI 40198459055356 (case), 10198459055355 (ea) Lots 25FBM604 25GBP604; DYNJ909124F UDI-DI 40198459130619 (case), 10198459130618 (ea) Lots 25FBB831 25GBI833

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 4 of 10

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D

Z-0445-2026
Recall number
Z-0445-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

ENT DYNJ909128I UDI-DI 40198459333355 (case), 10198459333354 (ea) Lots 25GBO685; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D UDI-DI 40198459055301 (case), 10198459055300 (ea) Lots 25GBN602

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 5 of 10

DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

Z-0446-2026
Recall number
Z-0446-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

CYSTO DYNJ909127F UDI-DI 40198459055424 (case), 10198459055423 (ea) Lots 25FBP819 25GBM605; GENERAL LAPAROSCOPY-LF DYNJ909129D UDI-DI 40198459055264 (case), 10198459055263 (ea) Lots 25FBV537; ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909119G UDI-DI 40198459130527 (case), 10198459130526 (ea) Lots 25FBP681

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 6 of 10

Convenience Kit, BREAST HERNIA DYNJ909125G

Z-0447-2026
Recall number
Z-0447-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

DYNJ909125G UDI-DI 40198459130664 (case), 10198459130663 (ea) Lot 25FBU543 25IBD459

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 7 of 10

Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING

Z-0448-2026
Recall number
Z-0448-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

HIP PINNING DYNJ909308D UDI-DI 40198459055288 (case), 10198459055287 (ea) Lots 25FBB311 25GBC282 25GBW486; ORTHO SPINE ST CLAIR DYNJ901048N UDI-DI 40198459055554 (case), 10198459055553 (ea) Lots 25GBQ070; SET UP DYNJ909132F UDI-DI 40198459130572 (case), 10198459130571 (ea) Lots 25GBI845 25IBF708; UROLOGY MINOR DYNJ909123F UDI-DI 40198459130602 (case), 10198459130601 (ea) Lots 25GBT826 25IBF707

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 8 of 10

Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230

Z-0449-2026
Recall number
Z-0449-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 UDI-DI 40884389688589 (case), 10884389688588 (ea) Lots 25EBV570 25FBT843

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 9 of 10

Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE

Z-0450-2026
Recall number
Z-0450-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

GYN ROBOTIC DYNJ901046M UDI-DI 40198459130381 (case), 10198459130380 (ea) Lots 25FBM810 25GBK307; ROBOTIC PROSTATE DYNJ909120D UDI-DI 40198459130541 (case), 10198459130540 (ea) Lots 25GBT821 25IBF809

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

device · product 10 of 10

Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY

Z-0451-2026
Recall number
Z-0451-2026
Initiated
October 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96,406 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Code information

DR SALMA'S SPINE DYNJ909111F UDI-DI 40198459130794 (case), 10198459130793 (ea) Lots 25FBE036 25GBV759; ORTHO SPINE FUMICH DYNJ901047R UDI-DI 40198459130466 (case), 10198459130465 (ea) Lots 25FBR230 25GBU693; PATTERSON TOTAL JOINT DYNJ909117G UDI-DI 40198459130480 (case), 10198459130489 (ea) Lots 25FBO307 25GBN625; TOTAL JOINT DYNJ902308K UDI-DI 40198459130596 (case), 10198459130595 (ea) Lots 25FBB321 25GBU688 KYPHOPLASTY DYNJ909113F UDI-DI 40198459130459 (case), 10198459130458 (ea) Lot 25IBM788

Distribution pattern

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;