Browse Device Recalls

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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 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 Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A2... Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monit... Class II Philips Medical Systems, 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 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 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 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 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 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 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 6, 2013 AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal de... The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complet... Class II Sybron Dental Specialties
Jun 5, 2013 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... Class III 3M Company - Health Care Business
May 31, 2013 Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting... The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column ... Class II Synthes (USA) Products LLC
May 30, 2013 Exactech Articulated Driver A nonpowered hand-held device intended for me... When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift ou... Class II Exactech, Inc.
May 29, 2013 Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTI... The information regarding the FILM Mode calibration may have been considered difficult to interpr... Class II Siemens Medical Solutions USA, Inc
May 29, 2013 Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM T... A plate was inadvertently released to a sales consultant that was restricted for sale. Class II Synthes USA HQ, Inc.
May 24, 2013 AMICUS Exchange Kit; Product Usage: This kit is designed for use with th... Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339... Class II Fenwal Inc
May 23, 2013 Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation

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.