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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jul 29, 2024 DR 800. Digital Radiography X-ray System. Potential for the front lever chain of the DR 800 table to fail. Class II Agfa N.V.
Feb 23, 2024 Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray ... Steel cable installed inside the mobile column which supports the weight of the telescopic arm wi... Class II Agfa N.V.
Apr 6, 2020 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type numbe... Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calcula... Class II Agfa N.V.
Feb 10, 2020 AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomograph... Tomosynthesis image acquisition sequence did not stop automatically after expected number of expo... Class II Agfa N.V.
Jun 27, 2019 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product ... The exposed area of fluo exams possibly does not match the active area of the detector within spe... Class II Agfa N.V.
Jan 25, 2019 PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, ... Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibi... Class III Agfa N.V.
Aug 15, 2018 DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General ... A supplier for the Agfa system noted a potential for the steel support cables of a similar device... Class II Agfa N.V.

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.