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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Sep 25, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the... Class I Elekta Instrument AB
Mar 15, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... Class I Elekta Instrument AB
Mar 1, 2023 Instructions for Use for the following Leksell Stereotactic System and Leksel... The incorrect IFU was distributed with the devices. Class II Elekta Instrument AB
Jun 10, 2020 Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may ... Class II Elekta Instrument AB
Jun 27, 2018 Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-bas... The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of... Class II Elekta Instrument AB

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.