Browse Device Recalls
57 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 57 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 57 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 22, 2021 | BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French;... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Oct 16, 2020 | CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector | Detachment of the Male AIV Adaptor from the Y-Connector. | Class II | Avanos Medical, Inc. |
| Jul 29, 2020 | AVANOS MIC-KEY SF Gastrostomy Feeding Tube | Devices had cracked or detached from the feeding tube body | Class II | Avanos Medical, Inc. |
| Mar 16, 2020 | CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit | The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causin... | Class II | Avanos Medical, Inc. |
| Nov 5, 2019 | Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-... | Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric... | Class II | Avanos Medical, Inc. |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, Inc. |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, 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.