Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
Jun 10, 2013 Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributo... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System Tibial Articular Surface Provisio... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 8, 2013 da Vinci Instrument Control Box, model number ICB3000; Manufactured by Int... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuit... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intu... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intui... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 7, 2013 MedStream Programmable Infusion Pump , Implantable for the intrathecal delive... Miscalibrated Fill Level Sensor may affect dosing level Class I Codman & Shurtleff, Inc.
Jun 7, 2013 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workst... Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer... Class II Del Mar Reynolds Medical, Ltd.
Jun 7, 2013 00597001131 Femur CR PRC SURF HDN FEM CO-N... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administrat... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 0059500... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-F... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 005... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6A... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor:... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Multirate Infusor Devices. Indicated for the intravenous admin... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
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 Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Bax... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... Class II Baxter Healthcare Corp.
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.

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.