Browse Device Recalls
15 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 15 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 15 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 2, 2018 | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one... | Class II | Shippert Medical Technologies | |
| Feb 2, 2018 | Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patie... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one... | Class II | Shippert Medical Technologies | |
| Feb 2, 2018 | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, on... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Oct 20, 2017 | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat tr... | Potential breach of sterility of the packaging. | Class II | Shippert Medical Technologies |
| Jun 1, 2017 | Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for ... | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Shippert Medical Technologies |
| Jun 1, 2017 | Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for ... | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Shippert Medical Technologies |
| Jun 1, 2017 | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for ... | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Shippert Medical Technologies |
| Jun 1, 2017 | Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat tr... | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Shippert Medical Technologies |
| Jun 1, 2017 | Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat tr... | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Shippert Medical Technologies |
| Jun 1, 2017 | Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat ... | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Shippert Medical Technologies |
| Jun 1, 2017 | Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fa... | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Shippert Medical Technologies |
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.