Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 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 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 3, 2022 | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product wa... | The packaging may not be sealed, which could compromise sterility. | Class II | Collagen Matrix Inc |
| Nov 5, 2019 | GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 -... | The products may have been packaged with an incorrect Instructions for Use. | Class II | Collagen Matrix Inc |
| Nov 5, 2019 | GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Prod... | The products may have been packaged with an incorrect Instructions for Use. | Class II | Collagen Matrix Inc |
| Nov 5, 2019 | GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Prod... | The products may have been packaged with an incorrect Instructions for Use. | Class II | Collagen Matrix Inc |
| Nov 5, 2019 | GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Prod... | The products may have been packaged with an incorrect Instructions for Use. | Class II | Collagen Matrix Inc |
| Nov 5, 2019 | GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 -... | The products may have been packaged with an incorrect Instructions for Use. | Class II | Collagen Matrix Inc |
| Nov 5, 2019 | GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 -... | The products may have been packaged with an incorrect Instructions for Use. | Class II | Collagen Matrix Inc |
| Oct 30, 2018 | Porcine Anorganic Bone Mineral 4.0cc | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume an... | Class III | Collagen Matrix Inc |
| Nov 17, 2015 | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in... | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working pr... | Class III | Collagen Matrix Inc |
| Aug 25, 2015 | NuOSS Cancellous Intended for use in dental surgery. | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous produ... | Class II | Collagen Matrix Inc |
| May 13, 2013 | NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm he... | During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the ... | Class II | Collagen Matrix 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.