Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), p... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 29961... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 2... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in carton... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog #... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| 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 |
| Jun 4, 2013 | Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in d... | Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently deter... | Class II | Mesa Laboratories, Inc., Bozeman Manufacturing ... |
| Jun 4, 2013 | Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended fo... | Self-contained steam biological indicator, are recalled because Mesa recently determined that the... | Class II | Mesa Laboratories, Inc., Bozeman Manufacturing ... |
| Jun 3, 2013 | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... | Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon... | Class II | Alere San Diego, Inc. |
| Jun 3, 2013 | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the ... | As a result of a quality review, labelling content discrepancies were identified between the Inst... | Class III | Integra LifeSciences Corp. |
| May 31, 2013 | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, use... | Electrical power module installed on some in vitro diagnostic instruments does not meet industry ... | Class III | Becton Dickinson & Co. |
| 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 | Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Use... | Medical devices were incorrectly labeled with extended expiration dates. | Class II | Terumo Medical Corporation |
| May 30, 2013 | Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Ti... | Medical devices were incorrectly labeled with extended expiration dates. | Class II | Terumo Medical 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.