Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Jun 7, 2013 00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 F... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 0059870... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Fem... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 9... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 005971011... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597001101 Femur CR PRECOAT FEM COMP SIZE... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 0... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 0... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 0059... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 0059... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Fem... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 0059... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 0059720612... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femu... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 905... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-F... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 005970... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Ster... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, 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.