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Browse Device Recalls

135 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 135 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 135 FDA device recalls.

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DateProductReasonClassFirm
Oct 11, 2013 VERSYS HERITAGE FEM STEM Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUB... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Bipolar liners and Multipolar cups with the following dimensions in MM (38, 3... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes s... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM P... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE P... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 6 DEGREE COCR FEM HEAD 36 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HGP II ACETABULAR CUP BON Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HGP II ACETABULAR CUP MOD Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541,... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ASIA ONE-PIECE LAG SCREW Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ZIMTRON 6 DEG 22 HEADS Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIU... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item co... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 00... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 CPT 12/14 COCR (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENE... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SEL... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 PRESSFIT FEM ST FX 16 X 1 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRU... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELF... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.