Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 19, 2013 Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A,... The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect... Class II Philips Healthcare Inc.
Jun 19, 2013 Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands ar... Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particul... Class II Edwards Lifesciences, LLC
Jun 17, 2013 Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 17, 2013 Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 14, 2013 Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 11, 2013 Synthes Flexible Medullary Reamer. Intended to be used to facilitate the p... Due to the coiled design for this product, the product is difficult to clean and the potential fo... Class II Synthes USA HQ, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provi... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provi... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Prov... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, 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 10, 2013 Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provi... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, 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 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 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 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 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 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 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 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 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 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 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 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.

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.