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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
Jun 24, 2022 ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... Class III Zeiss, Carl Inc
Oct 2, 2019 Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) When the user tilts the transmitted light arm of the microscope to the end of its axis range, las... Class II Zeiss, Carl Inc
May 29, 2018 Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-... Class II Zeiss, Carl Inc
May 8, 2018 Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightS... In certain eyepiece configurations the laser shutter may not close completely, permitting reflect... Class II Zeiss, Carl Inc
Dec 20, 2013 Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utiliz... Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on S... Class II Zeiss, Carl Inc
May 28, 2013 Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss... Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS micro... Class II Zeiss, Carl Inc

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.