Browse Device Recalls
6 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 6 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 6 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 11, 2019 | da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical... | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increas... | Class II | Intuitive Surgical Inc |
| Apr 11, 2019 | da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical ... | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increas... | Class II | Intuitive Surgical Inc |
| Jun 13, 2014 | Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction wi... | Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the inst... | Class II | Intuitive Surgical, Inc. |
| Jun 11, 2014 | IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Int... | In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... | Class II | Intuitive Surgical, Inc. |
| Jun 11, 2014 | IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Int... | In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, ... | Class II | Intuitive Surgical, Inc. |
| Apr 27, 2012 | Patient Side Cart Battery Box used in conjunction with the da Vinci A surgica... | Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. | Class II | Intuitive Surgical, 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.