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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94136

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

Open FDA event record

Event summary

Timeline bucket
February 23, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

29 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 29

Centurion STERILE TRACH BRUSH, Product Code 6225ST

Z-1427-2024
Recall number
Z-1427-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
1700

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 50653160004750 (case), 00653160004755 (each), Lot Numbers: 2023021090

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 2 of 29

Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575

Z-1428-2024
Recall number
Z-1428-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
480 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 00653160352054 (case), 10653160352051 (each), Lot Numbers: 2023071390

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 3 of 29

Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6

Z-1429-2024
Recall number
Z-1429-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
100 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 10653160129257 (case), 00653160129250 (each), Lot Numbers: 2023022290, 2023042490

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 4 of 29

Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST

Z-1430-2024
Recall number
Z-1430-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
1350 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 20653160172663 (case), 00653160172669 (each), Lot Numbers: 2023042690, 2023103090

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 5 of 29

Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760

Z-1431-2024
Recall number
Z-1431-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
2310 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) DH760, UDI/DI 20653160237713 (case), 00653160237719 (unit), Lot Numbers: 2023042790; b) 9125ST6, UDI/DI 10653160129257 (case), 00653160129250 (unit), Lot Numbers: 2023060790; c) DH760, UDI/DI 20653160237713 (case), 00653160237719 (unit), Lot Numbers: 2023110990

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 6 of 29

Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830

Z-1432-2024
Recall number
Z-1432-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
100 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 10653160196648 (case), 00653160196641 (unit), Lot Numbers: 2023042590

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 7 of 29

Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505

Z-1433-2024
Recall number
Z-1433-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
440 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 00653160294453 (case), 10653160294450 (unit), Lot Numbers: 2023090190, 2023101190

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 8 of 29

Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535

Z-1434-2024
Recall number
Z-1434-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
760 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 66795, UDI/DI 50653160061180 (case) 00653160061185 (each), Lot Numbers: 2023030190, 2023052390, 2023092590; b) 67525, UDI/DI 10653160158639 (case) 00653160158632 (ease), Lot Numbers: 2023032490; c) 37535, UDI/DI 10653160169048 (case) 00653160169041 (each), Lot Numbers: 2023061490

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 9 of 29

Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655

Z-1435-2024
Recall number
Z-1435-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
1520 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 66660, UDI/DI 60653160052154 (case) 00653160052152 (each), Lot Numbers: 2023042790, 2023091190; b) 67105, UDI/DI 60653160061880 (case) 00653160061888 (each), Lot Numbers: 2023042690; c) 67810, UDI/DI 30653160196703 (case) 00653160196702 (each), Lot Numbers: 2023060790, 2023070790; d) I68655, UDI/DI 00653160317220 (case) 10653160317227 (each), Lot Numbers: 2023061290

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 10 of 29

Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290

Z-1436-2024
Recall number
Z-1436-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
3860 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 66825, UDI/DI 60653160053588 (case) 00653160053586 (each), Lot Numbers: 2023091990, 2023111590; b) I68290 UDI/DI 00653160275056 (case) 10653160275053 (each), Lot Numbers: 2023100690

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 11 of 29

Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M

Z-1437-2024
Recall number
Z-1437-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
274410 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

Centurion: a) 66165, UDI/DI 60653160018334 (case) 00653160018332 (each), Lot Numbers: 2023111790; b) 66185, UDI/DI 60653160004887 (case) 00653160004885 (each), Lot Numbers: 2023041090, 2023072590, 2023120190; c) 66195, UDI/DI 60653160006638 (case) 00653160006636 (each), Lot Numbers: 2023042090, 2023053090, 2023090890, 2023111790; d) 66200, UDI/DI 60653160022607 (case) 00653160022605 (each), Lot Numbers: 2023020890; e) 66205, UDI/DI 60653160031944 (case) 00653160031942 (each), Lot Numbers: 2023030390; f) 66220, UDI/DI 60653160024809 (case) 00653160024807 (each), Lot Numbers: 2023111490; g) 66275, UDI/DI 60653160038882 (case) 00653160038880 (each), Lot Numbers: 2023060690; h) 66280, UDI/DI 60653160004870 (case) 00653160004878 (each), Lot Numbers: 2023113090; i) 66355, UDI/DI 60653160023277 (case) 00653160023275 (each), Lot Numbers: 2023042790; j) 66360, UDI/DI 50653160022365 (case) 00653160022360 (each), Lot Numbers: 2023032090; k) 66375, UDI/DI 60653160004856 (case) 00653160004854 (each), Lot Numbers: 2023032790, 2023112990, 2023113090; l) 66395, UDI/DI 60653160044036 (case) 00653160044034 (each), Lot Numbers: 2023071890; m) 66415, UDI/DI 60653160018815 (case) 00653160018813 (each), Lot Numbers: 2023041390, 2023101390; n) 66430, UDI/DI 20653160041211 (case) 00653160041217 (each), Lot Numbers: 2023032390; o) 66440, UDI/DI 70653160022352 (case) 00653160022353 (each), Lot Numbers: 2023100990, 2023102790; p) 66470, UDI/DI 10653160039389 (case) 00653160039382 (each), Lot Numbers: 2023070390; q) 66490, UDI/DI 10653160009030 (case) 00653160009033 (each), Lot Numbers: 2023021690; r) 66500, UDI/DI 60653160043848 (case) 00653160043846 (each), Lot Numbers: 2023031090; s) 66510, UDI/DI 10653160050520 (case) 00653160050523 (each), Lot Numbers: 2023071290; t) 66515, UDI/DI 60653160040953 (case) 00653160040951 (each), Lot Numbers: 2023041090, 2023071290, 2023111590; u) 66560, UDI/DI 60653160018310 (case) 00653160018318 (each), Lot Numbers: 2023032090, 2023042490, 2023100390; v) 66570, UDI/DI 60653160038295 (case) 00653160038293 (each), Lot Numbers: 2023041890, 2023060790, 2023071990, 2023101390; w) 66595, UDI/DI 60653160038127 (case) 00653160038125 (each), Lot Numbers: 2023110890; x) 66605, UDI/DI 50653160006570 (case) 00653160006575 (each), Lot Numbers: 2023021390, 2023021690; y) 66655, UDI/DI 50653160011123 (case) 00653160011128 (each), Lot Numbers: 2023101790; z) 66755, UDI/DI 60653160031401 (case) 00653160031409 (each), Lot Numbers: 2023102690, 2023111390; aa) 66790, UDI/DI 50653160007676 (case) 00653160007671 (each), Lot Numbers: 2023021090, 2023110290; bb) 66830, UDI/DI 50653160042042 (case) 00653160042047 (each), Lot Numbers: 2023111490; cc) 66860, UDI/DI 10653160051268 (case) 00653160051261 (each), Lot Numbers: 2023021490, 2023032990; dd) 66865, UDI/DI 70653160040844 (case) 00653160040845 (each), Lot Numbers: 2023051990; ee) 66970, UDI/DI 60653160018792 (case) 00653160018790 (each), Lot Numbers: 2023033090, 2023072090, 2023100590; ff) 66975, UDI/DI 60653160026032 (case) 00653160026030 (each), Lot Numbers: 2023101290; gg) 67005, UDI/DI 10653160107415 (case) 00653160107418 (each), Lot Numbers: 2023100690; hh) 67015, UDI/DI 60653160007147 (case) 00653160007145 (each), Lot Numbers: 2023052290, 2023112190; ii) 67060, UDI/DI 10653160239338 (case) 00653160061697 (each), Lot Numbers: 2023041490, 2023041790; jj) 67115, UDI/DI 60653160006683 (case) 00653160006681 (each), Lot Numbers: 2023042490; kk) 67170, UDI/DI 10653160021360 (case) 00653160021363 (each), Lot Numbers: 2023072690; ll) 67175, UDI/DI 40653160101575 (case) 00653160101577 (each), Lot Numbers: 2023050890; mm) 67260, UDI/DI 50653160062330 (case) 00653160062335 (each), Lot Numbers: 2023032790; nn) 67310, UDI/DI 10653160103264 (case) 00653160103267 (each), Lot Numbers: 2023030390; oo) 67485, UDI/DI 10653160140924 (case) 00653160140927 (each), Lot Numbers: 2023042590, 2023101990; pp) 67505, UDI/DI 10653160146568 (case) 00653160146561 (each), Lot Numbers: 2023072090; qq) 67560, UDI/DI 10653160167877 (case) 00653160167870 (each), Lot Numbers: 2023100390; rr) 67590, UDI/DI 30653160183017 (case) 00653160183016 (each), Lot Numbers: 2023050890; ss) 67700, UDI/DI 30653160195898 (case) 00653160195897 (each), Lot Numbers: 2023061290, 2023071090; tt) 67720, UDI/DI 10653160196068 (case) 00653160196061 (each), Lot Numbers: 2023042590; uu) 67725, UDI/DI 10653160195931 (case) 00653160195934 (each), Lot Numbers: 2023032790; vv) 67740, UDI/DI 10653160196099 (case) 00653160196092 (each), Lot Numbers: 2023102790; ww) 67865, UDI/DI 10653160196839 (case) 00653160196832 (each), Lot Numbers: 2023042490; xx) 67870, UDI/DI 30653160196895 (case) 00653160196894 (each), Lot Numbers: 2023032790; yy) 67875, UDI/DI 30653160196901 (case) 00653160196900 (each), Lot Numbers: 2023042790; zz) 67885, UDI/DI 30653160197861 (case) 00653160197860 (each), Lot Numbers: 2023022290; aaa) 67910, UDI/DI 10653160202059 (case) 00653160202052 (each), Lot Numbers: 2023051990, 2023060690, 2023062090; bbb) 67915, UDI/DI 30653160202060 (case) 00653160202069 (each), Lot Numbers: 2023050590; ccc) 67925, UDI/DI 30653160206914 (case) 00653160206913 (each), Lot Numbers: 2023112790; ddd) 67940, UDI/DI 10653160210177 (case) 00653160210170 (each), Lot Numbers: 2023072790; eee) 67945, UDI/DI 10653160211150 (case) 00653160211153 (each), Lot Numbers: 2023072690; fff) 66200K, UDI/DI 10653160164166 (case) 00653160164169 (each), Lot Numbers: 2023042690; ggg) 66360K, UDI/DI 00653160352801 (case) 10653160352808 (each), Lot Numbers: 2023050490, 2023050890; hhh) 66430K, UDI/DI 00653160358605 (case) 10653160358602 (each), Lot Numbers: 2023030990, 2023062890; iii) 67310K, UDI/DI 00653160358612 (case) 10653160358619 (each), Lot Numbers: 2023030990; jjj) I67455, UDI/DI 00653160257083 (case) 10653160257080 (each), Lot Numbers: 2023061290; kkk) I67975, UDI/DI 30653160223614 (case) 00653160223613 (each), Lot Numbers: 2023042490; lll) I68030, UDI/DI 10653160228288 (case) 00653160228281 (each), Lot Numbers: 2023032090; mmm) I68035, UDI/DI 10653160228417 (case) 00653160228410 (each), Lot Numbers: 2023041090; nnn) I68255, UDI/DI 00653160268423 (case) 10653160268420 (each), Lot Numbers: 2023061490, 2023081490, 2023101390; ooo) I68320, UDI/DI 00653160278842 (case) 10653160278849 (each), Lot Numbers: 2023030990; ppp) I68420, UDI/DI 00653160287707 (case) 10653160287704 (each), Lot Numbers: 2023021090, 2023091890, 2023101990; qqq) I68435, UDI/DI 00653160289206 (case) 10653160289203 (each), Lot Numbers: 2023041190; rrr) I68440, UDI/DI 00653160289213 (case) 10653160289210 (each), Lot Numbers: 2023041190; sss) I86530, UDI/DI 00653160254686 (case) 10653160254683 (each), Lot Numbers: 2023062890; ttt) P-66200, UDI/DI 60653160022607 (case) 00653160022605 (each), Lot Numbers: 2023120590 (not distributed); uuu) TRI66525, UDI/DI 00653160317589 (case) 10653160317586 (each), Lot Numbers: 2023042490, 2023062690, 2023091190, 2023102790; vvv) TRI66575, UDI/DI 00653160317688 (case) 10653160317685 (each), Lot Numbers: 2023102790; www) TRI66725, UDI/DI 00653160317961 (case) 10653160317968 (each), Lot Numbers: 2023112890; xxx) TRI66800, UDI/DI 00653160317930 (case) 10653160317937 (each), Lot Numbers: 2023040490; yyy) TRI66875, UDI/DI 00653160317893 (case) 10653160317890 (each), Lot Numbers: 2023051290; zzz) TRI66875K, UDI/DI 00653160358599 (case) 10653160358596 (each), Lot Numbers: 2023030990; aaaa) TRI66950, UDI/DI 00653160317916 (case) 10653160317913 (each), Lot Numbers: 2023060790; MEDLINE: a) DYND04009, UDI/DI 20193489191353 (case) 10193489191356 (each), Lot Numbers: 2023102490; b) DYND04010, UDI/DI 40884389096469 (case) 10884389096468 (each), Lot Numbers: 2023033190, 2023040390, 2023060290, 2023062190, 2023072090, 2023091990, 2023092990, 2023111690; c) DYNJ04048, UDI/DI 20193489195245 (case) 10193489195248 (each), Lot Numbers: 2023031090, 2023032890, 2023041890, 2023050390, 2023060890, 2023071190, 2023072590, 2023081590, 2023101990, 2023102890, 2023110890, 2023111590, 2023112290, 2023112890; d) DYNJ04052, UDI/DI 20193489195252 (case) 10193489195255 (each), Lot Numbers: 2023021590, 2023111390

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 12 of 29

Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175; e) STERILE CURV SATIN HEMOSTAT (MHS103S), Product Code 66445; f) STERILE STRT SATIN HEMOSTAT (MHS102S), Product Code 66485; g) STERILE STRT KELLY HEMOSTAT (SK8039S), Product Code 66695; h) STERILE STRAIGHT KELLY HEMOSTAT, Product Code 67140; i) ST. STR MOSQUITO HEMOSTAT 3 1/2"(MHB700), Product Code 67325; j) STERILE CVD MOSQT HEMOST 3 1/2"(MHB710), Product Code 67330; k) STERILE 8" CRVD KELLY HEMOSTAT (CK1008), Product Code 67655; l) STERILE 8" STR KELLY HEMOSTAT (SK1008), Product Code 67660; m) ST MOSQUITO HEMO CURVED FINE PT (P/S), Product Code I68100; n) ST CURVED KELLY HEMOSTAT-TAMPA GEN, Product Code I68310; o) STERILE STRT KELLY HEMOSTAT (ZM-09417), Product Code P-65240; p) STERILE STRT MOSQUITO HEMOSTAT (MHS102), Product Code TRI66140; q) STERILE CURVED KELLY HEMO (ST153), Product Code TRI66765

Z-1438-2024
Recall number
Z-1438-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
80903 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 65340, UDI/DI 10653160038023 (case) 00653160038026 (each), Lot Numbers: 2023041090, 2023061290, 2023091190; b) 66145, UDI/DI 70653160008783 (case) 00653160008784 (each), Lot Numbers: 2023042690, 2023042790, 2023072790; c) 66170, UDI/DI 70653160024035 (case) 00653160024036 (each), Lot Numbers: 2023031090, 2023041790; d) 66175, UDI/DI 60653160039575 (case) 00653160039573 (each), Lot Numbers: 2023031390, 2023050990, 2023082490, 2023103090; e) 66445, UDI/DI 70653160023779 (case) 00653160023770 (each), Lot Numbers: 2023070390, 2023071090; f) 66485, UDI/DI 60653160029200 (case) 00653160029208 (each), Lot Numbers: 2023042690, 2023090790; g) 66695, UDI/DI 60653160024861 (case) 00653160024869 (each), Lot Numbers: 2023042790; h) 67140, UDI/DI 60653160049871 (case) 00653160049879 (each), Lot Numbers: 2023112990; i) 67325, UDI/DI 10653160110675 (case) 00653160110678 (each), Lot Numbers: 2023042490; j) 67330, UDI/DI 30653160110730 (case) 00653160110739 (each), Lot Numbers: 2023042890; k) 67655, UDI/DI 10653160196006 (case) 00653160196009 (each), Lot Numbers: 2023030290; l) 67660, UDI/DI 10653160196013 (case) 00653160196016 (each), Lot Numbers: 2023031390, 2023101990; m) I68100, UDI/DI 10653160235811 (case) 00653160235814 (each), Lot Numbers: 2023041190, 2023060790; n) I68310, UDI/DI 00653160278835 (case) 10653160278832 (each), Lot Numbers: 2023022190; o) P-65240, UDI/DI 10653160359234 (case) 20653160359231 (each), Lot Numbers: 2023120590; p) TRI66140, UDI/DI 00653160317855 (case) 10653160317852 (each), Lot Numbers: 2023032890, 2023061690; q) TRI66765, UDI/DI 00653160317947 (case) 10653160317944 (each), Lot Numbers: 2023030990

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 13 of 29

Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00, Product Code I68040; f) STERILE BRUNS CURETTE #4 (BC400S), Product Code I68340; g) 6MM FOX DERMAL CURETTE STERILE, Product Code I68380; h) STERILE KEVORKIAN CURETTE 4MM (KEC4S), Product Code I68470; i) ST ENDOCERVICAL BIOPSY CURETTE 2MM, Product Code I68480

Z-1439-2024
Recall number
Z-1439-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
20614 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 66745, UDI/DI 70653160060330 (case) 00653160060331 (each), Lot Numbers: 2023103090; b) 67050, UDI/DI 00653160357509 (case) 10653160357506 (each), Lot Numbers: 2023103090; c) 67430, UDI/DI 10653160123514 (case) 00653160123517 (each), Lot Numbers: 2023022190; d) I67970, UDI/DI 20653160224744 (case) 00653160224740 (each), Lot Numbers: 2023041390, 2023041490, 2023061990, 2023101290; e) I68040, UDI/DI 20653160228605 (case) 00653160228601 (each), Lot Numbers: 2023022190, 2023102090; f) I68340, UDI/DI 00653160279863 (case) 10653160279860 (each), Lot Numbers: 2023042490; g) I68380, UDI/DI 00653160284553 (case) 10653160284550 (each), Lot Numbers: 2023032790, 2023101790; h) I68470, UDI/DI 00653160290721 (case) 10653160290728 (each), Lot Numbers: 2023032190, 2023032390; i) I68480, UDI/DI 00653160292640 (case) 10653160292647 (each), Lot Numbers: 2023013190

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 14 of 29

Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWEL CLAMPS 5 1/2", Product Code I68095; f) ZIPSER PENIS CLAMP STERILE (ZC110), Product Code ZC110ST

Z-1440-2024
Recall number
Z-1440-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
12980 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 66520, UDI/DI 60653160040960 (case) 00653160040968 (each), Lot Numbers: 2023111590; b) A547ST, UDI/DI 10653160113683 (case) 00653160113686 (each), Lot Numbers: 2023020990, 2023033090, 2023060790, 2023092990; c) I68080, UDI/DI 20653160232602 (case) 00653160232608 (each), Lot Numbers: 2023072790; d) I68085, UDI/DI 30653160232616 (case) 00653160232615 (each), Lot Numbers: 2023032290, 2023071790; e) I68095, UDI/DI 20653160232695 (case) 00653160232691 (each), Lot Numbers: 2023062690; f) ZC110ST, UDI/DI 00653160258462 (case) 10653160258469 (each), Lot Numbers: 2023022490, 2023041090, 2023052290, 2023062890

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 15 of 29

Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code 67285; g) STERILE 5 1/2" NAIL NIPPER (32195), Product Code 67365; h) STERILE 4 1/4" CUTICLE NIPPER (32908), Product Code 67420; i) STERILE ENGLISH ANVIL NAIL SPLITTER-5", Product Code 67595; j) STERILE UNIVERSAL RING CUTTER(FS02470), Product Code 67780; k) STERILE FINGER NAIL CLIPPER, Product Code 589784ST; l) BILLEAU EAR LOOP 4MM 6" LARGE, Product Code BEL46ST; m) PROBE WITH EYE, Product Code DYND04011; n) STERILE 9" MAYO SCISSOR (ST150), Product Code I67350; o) STRL ROCHESTER OCHSNER SATIN 7 1/4", Product Code I67695; p) CMP* NAIL NIPPER ANGLED 4.5, Product Code I67980; q) STERILE BILLEAU EAR LOOP 3MM, Product Code I67995; r) ST. ALLIGATOR FORCEP, POINTED, MICRO P/S, Product Code I68020; s) MOSQUITO HEMOSTAT FINE TIP, Product Code I68190; t) STERILE VAS DEFERENS CLAMP (VDC100S), Product Code I68200; u) LILLIE EAR HOOK, 7" STERILE (P/S), Product Code I68305; v) ST FOX DERMAL CURE, 4MM, 5 1/2 (32922), Product Code I68360; w) STERILE SKIN HOOK - SHARP (SH25754), Product Code I68415; x) ST. EYE LID SPECULUM WIRE ADULT (ES500P), Product Code I68460; y) STERILE NAIL RASP DOUBLE ENDED (NR100), Product Code I68500; z) ST. SCLERAL DEPRESSOR 5.5" (SD500), Product Code I68515; aa) STERILE NAIL SPLITTING FORCEP 4" (NS400), Product Code I68600; bb) STERILE 12" PROBE W/ EYE, Product Code I68840; cc) COMEDONE EXTRACTOR, STERILE (P/S), Product Code I86540; dd) STERILE SPATULA & PACKER, Product Code I86695; ee) STERILE - PHLBCTMY HOOK CRCHT STYL 6, Product Code I86875; ff) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code P-67285 MEDLINE PROBE WITH EYE, Product Code DYND04011

Z-1441-2024
Recall number
Z-1441-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
60075 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 66225, UDI/DI 60653160018327 (case) 00653160018325 (each), Lot Numbers: 2023070390; b) 66565, UDI/DI 20653160059865 (case) 00653160059861 (each), Lot Numbers: 2023022090; c) 66810, UDI/DI 60653160038547 (case) 00653160038545 (each), Lot Numbers: 2023042490; d) 66900, UDI/DI 60653160038868 (case) 00653160038866 (each), Lot Numbers: 2023030890, 2023100390, 2023111090; e) 67110, UDI/DI 50653160049751 (case) 00653160049756 (each), Lot Numbers: 2023042490, 2023051590, 2023110290; f) 67285, UDI/DI 50653160089139 (case) 00653160089134 (each), Lot Numbers: 2023081490, 2023101190; g) 67365, UDI/DI 10653160115120 (case) 00653160115123 (each), Lot Numbers: 2023040390, 2023090790, 2023101790, 2023110890; h) 67420, UDI/DI 10653160123491 (case) 00653160123494 (each), Lot Numbers: 2023100590; i) 67595, UDI/DI 10653160184553 (case) 00653160184556 (each), Lot Numbers: 2023032890, 2023101390; j) 67780, UDI/DI 10653160196662 (case) 00653160196665 (each), Lot Numbers: 2023071290; k) 589784ST, UDI/DI 40653160130681 (case) 00653160130683 (each), Lot Numbers: 2023020990, 2023030790, 2023042890; l) BEL46ST, UDI/DI 10653160227168 (case) 00653160227161 (each), Lot Numbers: 2023101890; m) DYND04011, UDI/DI 40884389097800 (case) 10884389097809 (each), Lot Numbers: 2023102090; n) I67350, UDI/DI 00653160286847 (case) 10653160286844 (each), Lot Numbers: 2023031390, 2023111790; o) I67695, UDI/DI 00653160263060 (case) 10653160263067 (each), Lot Numbers: 2023110290 (not distributed); p) I67980, UDI/DI 10653160224815 (case) 00653160224818 (each), Lot Numbers: 2023031690; q) I67995, UDI/DI 10653160227656 (case) 00653160227659 (each), Lot Numbers: 2023042690, 2023101790, 2023111090; r) I68020, UDI/DI 10653160228349 (case) 00653160228342 (each), Lot Numbers: 2023092990, 2023111590; s) I68190, UDI/DI 00653160263299 (case) 10653160263296 (each), Lot Numbers: 2023041390, 2023090790; t) I68200, UDI/DI 00653160263077 (case) 10653160263074 (each), Lot Numbers: 2023101890; u) I68305, UDI/DI 00653160277647 (case) 10653160277644 (each), Lot Numbers: 2023072090; v) I68360, UDI/DI 00653160280852 (case) 10653160280859 (each), Lot Numbers: 2023021490; w) I68415, UDI/DI 00653160286946 (case) 10653160286943 (each), Lot Numbers: 2023111790; x) I68460, UDI/DI 00653160289886 (case) 10653160289883 (each), Lot Numbers: 2023030990, 2023060690, 2023100390; y) I68500, UDI/DI 00653160293555 (case) 10653160293552 (each), Lot Numbers: 2023061490, 2023111390; z) I68515, UDI/DI 00653160293548 (case) 10653160293545 (each), Lot Numbers: 2023061290; aa) I68600, UDI/DI 00653160308334 (case) 10653160308331 (each), Lot Numbers: 2023042790; bb) I68840, UDI/DI 00653160331578 (case) 10653160331575 (each), Lot Numbers: 2023021690, 2023050890, 2023091890; cc) I86540, UDI/DI 00653160270907 (case) 10653160270904 (each), Lot Numbers: 2023041390; dd) I86695, UDI/DI 00653160291834 (case) 10653160291831 (each), Lot Numbers: 2023042090; ee) I86875, UDI/DI 00653160359190 (case) 10653160359197 (each), Lot Numbers: 2023032790; ff) P-67285, UDI/DI 50653160089139 (case) 00653160089134 (each), Lot Numbers: 2023120590 MEDLINE: UDI/DI 40884389097800 (case), 10884389097809 (each), Lot Numbers: 2023102090

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 16 of 29

Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL KIT, Product Code SUT20350 MEDLINE GENERAL PURPOSE INST. TRAY, Product Code DYNDA2346A

Z-1442-2024
Recall number
Z-1442-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
7950 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 66580, UDI/DI 10653160028963 (case) 00653160028966 (each), Lot Numbers: 2023041090; b) I86630, UDI/DI 00653160286540 (case) 10653160286547 (each), Lot Numbers: 2023101190; c) I86690, UDI/DI 00653160290752 (case) 10653160290759 (each), Lot Numbers: 2023103190; d) I86815, UDI/DI 00653160342291 (case) 10653160342298 (each), Lot Numbers: 2023112190; e) MNS12675, UDI/DI 00653160337341 (case) 10653160337348 (each), Lot Numbers: 2023070390; f) SUT20350, UDI/DI 00653160306552 (case) 10653160306559 (each), Lot Numbers: 2023022290, 2023041190, 2023042490, 2023052390, 2023101890 MEDLINE: UDI/DI 20193489191582 (case) 10193489191585 (each), Lot Numbers: 2023062290, 2023081490

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 17 of 29

Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355

Z-1443-2024
Recall number
Z-1443-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
1335 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) I68905, UDI/DI 00653160350944 (case) 10653160350941 (each), Lot Numbers: 2023012590, 2023042590; b) MNS11505, UDI/DI 00653160320213 (case) 10653160320210 (each), Lot Numbers: 2023022490, 2023071390; c) MNS11545, UDI/DI 00653160320305 (case) 10653160320302 (each), Lot Numbers: 2023021390; d) SUT21355, UDI/DI 00653160329223 (case) 10653160329220 (each), Lot Numbers: 2023060790

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 18 of 29

Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150; e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155; f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215; g) STERILE 5-1/2" S/S SCISSOR (SS507), Product Code 66260; h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350; i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365; j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450; k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465; l) STERILE CURV MAYO SCISSOR 5 1/2" (81310), Product Code 66665; m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710; n) STERILE 6 1/2" S/B SCISSOR (11109SB), Product Code 66820; o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845; p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885; q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890; r) STERILE CURVED METZENBAUM (ST142), Product Code 66895; s) STERILE B/B SCISSOR 6 1/2", Product Code 66995; t) STERILE 6 3/4" MAYO SCISSOR, Product Code 67160; u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165; v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185; w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450; x) STERILE 51/2" EPISIOTOMY SCISSOR (11140), Product Code 67645; y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650; z) STERILE REPROCESSED 6 1/2" S/B SCISSOR, Product Code 66820K; aa) ST METZENBAUM SCISSOR CURVED 9"(MBS90C), Product Code I68510; bb) ST UMBILICAL SCISSOR, CRVD, 4" (11148), Product Code I68575; cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790; dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600; ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K; ff) STERILE STR MAYO SCISSOR 5 1/2" (ST115), Product Code TRI67630 MEDLINE: MEDLINE manual surgical kits labeled as: a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000; b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133

Z-1444-2024
Recall number
Z-1444-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
568,849 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 65145, UDI/DI 60653160023758 (case) 00653160023756 (each), Lot Numbers: 2023071990, 2023100390; b) 65940, UDI/DI 70653160018805 (case) 00653160018806 (each), Lot Numbers: 2023112290; c) 65945, UDI/DI 60653160024823 (case) 00653160024821 (each), Lot Numbers: 2023041290, 2023042890, 2023050190, 2023051890, 2023051990, 2023052290, 2023052490, 2023052590, 2023062090, 2023071490, 2023071790, 2023090290, 2023110190; d) 66150, UDI/DI 60653160023765 (case) 00653160023763 (each), Lot Numbers: 2023041390, 2023071490, 2023091890, 2023101190; e) 66155, UDI/DI 70653160022970 (case) 00653160022971 (each), Lot Numbers: 2023030390, 2023032990, 2023033090, 2023041890, 2023071090; f) 66215, UDI/DI 60653160004863 (case) 00653160004861 (each), Lot Numbers: 2023052690, 2023102790; g) 66260, UDI/DI 60653160008366 (case) 00653160008364 (each), Lot Numbers: 2023022290; h) 66350, UDI/DI 50653160018306 (case) 00653160018301 (each), Lot Numbers: 2023062790, 2023091190; i) 66365, UDI/DI 10653160025672 (case) 00653160025675 (each), Lot Numbers: 2023041990, 2023072890; j) 66450, UDI/DI 60653160022348 (case) 00653160022346 (each), Lot Numbers: 2023022890, 2023030190; k) 66465, UDI/DI 10653160023067 (case) 00653160023060 (each), Lot Numbers: 2023063090; l) 66665, UDI/DI 60653160082717 (case) 00653160082715 (each), Lot Numbers: 2023061490, 2023071990, 2023100690; m) 66710, UDI/DI 70653160046341 (case) 00653160046342 (each), Lot Numbers: 2023111090; n) 66820, UDI/DI 60653160028289 (case) 00653160028287 (each), Lot Numbers: 2023061490, 2023101890; o) 66845, UDI/DI 60653160048058 (case) 00653160048056 (each), Lot Numbers: 2023090190; p) 66885, UDI/DI 50653160049256 (case) 00653160049251 (each), Lot Numbers: 2023030990; q) 66890, UDI/DI 60653160049246 (case) 00653160049244 (each), Lot Numbers: 2023040690, 2023041090, 2023100990; r) 66895, UDI/DI 50653160006563 (case) 00653160006568 (each), Lot Numbers: 2023102690; s) 66995, UDI/DI 60653160048393 (case) 00653160048391 (each), Lot Numbers: 2023032390, 2023110390; t) 67160, UDI/DI 50653160052195 (case) 00653160052190 (each), Lot Numbers: 2023032790; u) 67165, UDI/DI 60653160046962 (case) 00653160046960 (each), Lot Numbers: 2023030390; v) 67185, UDI/DI 60653160038745 (case) 00653160038743 (each), Lot Numbers: 2023042590, 2023112290; w) 67450, UDI/DI 30653160134989 (case) 00653160134988 (each), Lot Numbers: 2023100690; x) 67645, UDI/DI 30653160195850 (case) 00653160195859 (each), Lot Numbers: 2023021490, 2023060790, 2023112790; y) 67650, UDI/DI 30653160195867 (case) 00653160195866 (each), Lot Numbers: 2023030390; z) 66820K, UDI/DI 00653160351408 (case) 10653160351405 (each), Lot Numbers: 2023050890 (not distributed) aa) I68510, UDI/DI 00653160293074 (case) 10653160293071 (each), Lot Numbers: 2023031390, 2023091890; bb) I68575, UDI/DI 00653160306675 (case) 10653160306672 (each), Lot Numbers: 2023022290, 2023041190, 2023060790; cc) I68790, UDI/DI 00653160327656 (case) 10653160327653 (each), Lot Numbers: 2023101890, 2023111690; dd) TRI66600, UDI/DI 00653160317992 (case) 10653160317999 (each), Lot Numbers: 2023021490, 2023041190; ee) TRI66670K, UDI/DI 00653160358667 (case) 10653160358664 (each), Lot Numbers: 2023030990, 2023040690; ff) TRI67630, UDI/DI 00653160317923 (case) 10653160317920 (each), Lot Numbers: 2023100690, 2023112790; MEDLINE: a) DYND04000, UDI/DI 20193489191346 (case) 10193489191349 (each), Lot Numbers: 2023021490, 2023050390, 2023050590, 2023050790, 2023051090, 2023050690, 2023050890, 2023050990, 2023051190, 2023051290, 2023051390, 2023051690, 2023050490, 2023051890, 2023051990, 2023052090, 2023052290, 2023052390, 2023052590, 2023052690, 2023052790, 2023052990, 2023053090, 2023060190, 2023060490, 2023060790, 2023060990, 2023061090, 2023061390, 2023061490, 2023061590, 2023070690, 2023081790, 2023081890, 2023101690, 2023102490, 2023102590, 2023102790, 2023102890, 2023102690, 2023112290, 2023112390, 2023110790; b) DYND04133, UDI/DI 20193489191360 (case) 10193489191363 (each), Lot Numbers: 2023033190, 2023101890

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 19 of 29

Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105

Z-1445-2024
Recall number
Z-1445-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
23,290 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) TRI55405, UDI/DI 20193489112709 (case) 10193489112702 (each), Lot Numbers: 2023022390 b) 60265, UDI/DI 50653160090982 (case) 00653160090987 (each), Lot Numbers: 2023041190 MEDLINE: a) 60280, UDI/DI 20193489111948 I(case) 10193489111941 (each), Lot Numbers: 2023031790, 2023070590, 2023112790; b) 86125, UDI/DI 20193489111832 (case) 10193489111835 (each), Lot Numbers: 2023032090, 2023120490; c) SR60555, UDI/DI 20193489111955 (case) 10193489111958 (each), Lot Numbers: 2023111590; d) TRI44105, UDI/DI 20193489112730 (case) 10193489112733 (each), Lot Numbers: 2023072490

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 20 of 29

Centurion STERILE #16 RUBBER BAND, Product Code EB16

Z-1446-2024
Recall number
Z-1446-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
150 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 10653160129240 (case) 00653160129243 (each), Lot Numbers: 2023022290, 2023041190

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 21 of 29

Centurion PICC LINE SECUREMENT KIT, Product Code IVS565

Z-1447-2024
Recall number
Z-1447-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
300 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 10653160175971 (case) 00653160175974 (each), Lot Numbers: 2023070790

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 22 of 29

Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST

Z-1448-2024
Recall number
Z-1448-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
1700 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 15MLVLCP, UDI/DI 50653160021306 (case) 00653160021301 (each), Lot Numbers: 2023102790 b) MG912ST, UDI/DI 10653160122906 (case) 00653160122909 (each), Lot Numbers: 2023022190

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 23 of 29

Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670

Z-1449-2024
Recall number
Z-1449-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
84224 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) 65140, UDI/DI 60653160008380 (case) 00653160008388 (each), Lot Numbers: 2023060790, 2023101090; b) 65840, UDI/DI 60653160010208 (case) 00653160010206 (each), Lot Numbers: 2023022790, 2023041190; c) 66240, UDI/DI 60653160008793 (case) 00653160008791 (each), Lot Numbers: 2023112790; d) 66855, UDI/DI 50653160007188 (case) 00653160007183 (each), Lot Numbers: 2023022490, 2023041990, 2023102690; e) 67225, UDI/DI 50653160001766 (case) 00653160001761 (each), Lot Numbers: 2023031690, 2023111490; f) TRI66670, UDI/DI 10653160317975 (case) 20653160317972 (each), Lot Numbers: 2023031490, 2023040690, 2023041090, 2023062790, 2023062890, 2023072490, 2023101690, 2023110190, 2023110990

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 24 of 29

Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930

Z-1450-2024
Recall number
Z-1450-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
270 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

a) HUD112ST, UDI/DI 50653160068288 (case) 00653160068283 (each), Lot Numbers: 2023032190; b) HUD12ST, UDI/DI 00653160288810 (case) 10653160288817 (each), Lot Numbers: 2023061690, 2023112990; c) HUD56ST, UDI/DI 50653160068257 (case) 00653160068252 (each), Lot Numbers: 2023112190; d) HUD910ST, UDI/DI 50653160068271 (case) 00653160068276 (each), Lot Numbers: 2023031390; e) I68920, UDI/DI 00653160351323 (case) 10653160351320 (each), Lot Numbers: 2023110290; f) I68930, UDI/DI 00653160351293 (case) 10653160351290 (each), Lot Numbers: 2023110990

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 25 of 29

Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335

Z-1451-2024
Recall number
Z-1451-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
1350 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 00653160349771 (case) 10653160349778 (each), Lot Numbers: 2023111090

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 26 of 29

MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A

Z-1452-2024
Recall number
Z-1452-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
4200 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 20193489111375 (case) 10193489111378 (each), Lot Numbers: 2023031590, 2023070390

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 27 of 29

MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724

Z-1453-2024
Recall number
Z-1453-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
2458 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 20193489190790 (case) 10193489190793 (each), Lot Numbers: 2023071290, 2023091890

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 28 of 29

MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006

Z-1454-2024
Recall number
Z-1454-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
800 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 40884389097350 (case) 10884389097359 (each), Lot Numbers: 2023031390

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

device · product 29 of 29

MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723

Z-1455-2024
Recall number
Z-1455-2024
Initiated
February 23, 2024
Classification
Class II
Status
Ongoing
Quantity
0

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Code information

UDI/DI 20193489190844 (case)10193489190847 (each), Lot Numbers: 2023071290 (not distributed)

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.