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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
Oct 28, 2021 Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray... It was noticed in production on 28.10.2021, that the final testing database gives a pass result f... Class II Palodex Group Oy
Jan 7, 2020 KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... Class II Palodex Group Oy
Jan 7, 2020 Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... Class II Palodex Group Oy
Jan 7, 2020 Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... Class II Palodex Group Oy
Jan 7, 2020 Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL I... Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... Class II Palodex Group Oy
Jan 14, 2014 The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Ma... Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013... Class II Instrumentarium Dental, PaloDEx Group Oy

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.