Browse Device Recalls

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

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DateProductReasonClassFirm
Feb 25, 2014 Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FL... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 19, 2014 Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon I... The possibility exists that an incomplete seal on the packaging compromised the sterility of the ... Class II Ethicon, Inc.
Feb 19, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, ... Class II Gyrus Medical, Inc
Feb 7, 2014 MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: ... Tyvek packaging may be worn, causing loss of package integrity. Class II Biocardia, Inc.
Feb 7, 2014 FMP X-alt Acetabular Liner This acetabular liner is intended for use with ... Packaging error -- two different types and sizes of acetabular liners used during hip replacement... Class II Djo Surgical
Feb 3, 2014 Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalo... Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angl... Class II Stryker Howmedica Osteonics Corp.
Dec 11, 2013 Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur... Class II Coltene Whaledent Inc
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock ... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 5, 2013 DIST LAT FEM LOCK PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 ITST THREADED GUIDE PIN Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 FEM COND BUTTRESS PLT, RT. Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 TIBIO FEM/FEM NAIL. Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 TIB NAIL Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 FEM COND BUTTRESS PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 DIST LAT FEM LOCK PLT, RT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 NGK Stem Ext 24 x 245mm Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Oct 25, 2013 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Ang... Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was iden... Class II Stryker Howmedica Osteonics Corp.
Oct 23, 2013 Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette,... Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-99... Class III Alere San Diego, Inc.
Oct 21, 2013 Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue ... Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During s... Class II Applied Medical Resources Corp
Oct 11, 2013 PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM ... 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 MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 4... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LA... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE L... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 FEM HD ION (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM a... 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 (various sizes) and 6 DEG UNIPOLAR FEMORAL HE Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
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.

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.