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 |
|---|---|---|---|---|
| Apr 22, 2015 | regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit contain... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - sur... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical ki... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 16, 2015 | MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 16, 2015 | Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 16, 2015 | Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM M... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 16, 2015 | Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 14, 2015 | AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray... | If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting s... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shapi... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bon... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting sh... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. C... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cut... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cut... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bon... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bo... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting sha... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutti... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shapin... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cu... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including sp... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shapin... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting s... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, 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.