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Browse Device Recalls

56 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 56 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 56 FDA device recalls.

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DateProductReasonClassFirm
Feb 21, 2012 Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-... The firm recalled due to a potentail problem with the position of the hold in the lug teminals on... Class II Toshiba American Medical Systems Inc
Nov 30, 2011 TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to ... The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) ... Class II Toshiba American Medical Systems Inc
Jul 13, 2009 Whole Body X--ray Scanner This device is indicated as a whole body volume ... 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw dat... Class II Toshiba American Medical Systems Inc
May 13, 2008 TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanne... The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis... Class II Toshiba American Medical Systems Inc
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
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

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.