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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Nov 18, 2025 Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic... It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro ... Class II AGFA Healthcare Corp.
Dec 22, 2016 IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database an... A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV ... Class II AGFA Healthcare Corp.
Dec 21, 2016 Agfa Healthcare NX 3.0.8950 Imaging Processing Software A customer reported that when using an NX workstation with software version NX 3.0.8950 software ... Class II AGFA Healthcare Corp.
May 2, 2016 DX-D600 - DXD Imaging Package One of the dent markers from the DX-D600 dropped down from the overhead rail. Class II AGFA Healthcare Corp.
Jan 20, 2016 AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use i... The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manuall... Class II AGFA Healthcare Corp.
Sep 1, 2015 IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IM... Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not produc... Class II AGFA Healthcare Corp.
Jun 26, 2015 IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archi... Firm received a complaint that the hospital had sent two accession numbers over the same morning ... Class II AGFA Healthcare Corp.
May 29, 2015 AGFA DX-D 100 is a mobile digital radiography x-ray system When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge ... Class II AGFA Healthcare Corp.
Oct 24, 2014 Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12... Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin lin... Class III AGFA Healthcare Corp.
Jul 16, 2014 Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355;... Some sheets of the medical screen film are fogged. Class III AGFA Healthcare Corp.
Jul 2, 2014 DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in provi... Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tu... Class II AGFA Healthcare Corp.
May 13, 2014 Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicate... Unit was mislabeled with a factory label showing 32 KW output power. Class III AGFA Healthcare Corp.

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.