Browse Device Recalls
4,606 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,606 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 4,606 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 13, 2008 | EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Ima... | The status display in the sequence queue window may not change from "Current" to "Done". | Class II | Toshiba American Medical Systems Inc |
| May 1, 2008 | PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an auto... | Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, ... | Class II | Dako North America Inc. |
| Feb 27, 2008 | Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based c... | The systems all have a similar table control board. It has been found that this board may cause ... | Class II | Toshiba American Medical Systems Inc |
| Oct 29, 2007 | Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model... | The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark... | Class II | Respironics California Inc |
| Sep 14, 2007 | HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution... | Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode bec... | Class II | Advanced Bionics Corporation |
| Dec 11, 1930 | Patient Cart used in conjunction with the da Vinci S surgical and SI System. ... | Increased number of complaints regarding fluid entering the patient card base of the da Vinci S a... | 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.