Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; ...
FDA Device Recall #Z-1437-2024 — Class II — February 23, 2024
Recall Summary
| Recall Number | Z-1437-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 23, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 274410 units |
Product Description
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
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Lot / 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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.