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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.

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DateProductReasonClassFirm
Apr 1, 2025 myQA iON; Article Number: MQ10-000; Wrong analysis results can occur if the user creates two structures with the same name, except fo... Class II IBA Dosimetry GmbH
Apr 26, 2017 Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50... When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the ... Class II Iba Dosimetry
Dec 10, 2015 IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2 When the electric lift table is connected to the mains power, in a very rare occasion, the table ... Class II Iba Dosimetry Gmbh
Feb 2, 2015 COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, ... Error in the software. During internal tests of the current development version of the Compass ... Class II Iba Dosimetry Gmbh
Sep 25, 2014 COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear ... Error in the software. A deviation between reconstructed and planned dose distribution may not b... Class II Iba Dosimetry Gmbh
Aug 20, 2013 iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerat... The development partner of IBA informed that there is problem in a SW component used in COMPASS w... Class II Iba Dosimetry Gmbh

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.