Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm, Item Number: 814611320 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm, Item Number: 814313260 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 420 mm, Item Number: 814509420 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 440 mm, Item Number: 814513440 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm, Item Number: 814311280 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 460 mm, Item Number: 814313460 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm, Item Number: 814513380 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 380 mm, Item Number: 814313380 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 260 mm, Item Number: 814509260 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 360 mm, Item Number: 814313360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 340 mm, Item Number: 814413340 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 280 mm, Item Number: 814611280 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 460 mm, Item Number: 814311460 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm, Item Number: 814613360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 380 mm, Item Number: 814511380 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 320 mm, Item Number: 814313320 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnifi... | Potential for the optical head to detach from the stand due to the lack of thread adhesive. | Class II | Alcon Research Laboratories Ltd. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 320 mm, Item Number: 814609320 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 320 mm, Item Number: 814411320 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 380 mm, Item Number: 814411380 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 360 mm, Item Number: 814413360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 420 mm, Item Number: 814611420 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm, Item Number: 814513340 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr dou... | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen c... | Class II | Arrow International Inc |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm, Item Number: 814311300 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient tra... | The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled p... | Class II | Liko AB |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, 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.