Browse Device Recalls
14 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 14 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 14 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 26, 2013 | Presource PBDS, General Laparoscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Extremity, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Knee, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Major Abdominal, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Joint, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Hip, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Gyn Laparoscopy Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood L... | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Hand, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Shoulder Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Shoulder Procedure, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
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.