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Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product C...

FDA Device Recall #Z-1441-2024 — Class II — February 23, 2024

Recall Summary

Recall Number Z-1441-2024
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 60075 units

Product Description

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

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

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

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Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
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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.

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