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Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 FDA device recalls.

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DateProductReasonClassFirm
Mar 16, 2022 ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during catar... High friction of the slider can cause the device to stick, or not move as intended. Class II Carl Zeiss Meditec AG
Dec 7, 2020 IOLMaster 700 When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient ... Class II Carl Zeiss Meditec AG
Aug 6, 2020 Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device ... Due to the incorrect DC/DC converter being assembled onto the communication board. As a result t... Class II Carl Zeiss Meditec AG
Aug 6, 2020 Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnosti... Due to the incorrect DC/DC converter being assembled onto the communication board. As a result t... Class II Carl Zeiss Meditec AG
Jun 25, 2018 Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMa... Calibration setting was incorrectly entered during manufacturing causing the optical coherence to... Class II Carl Zeiss Meditec AG
Aug 30, 2017 Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the... The device had an incorrect printed calibration value on the calibration certificate. Class II Carl Zeiss Meditec AG
Oct 27, 2015 IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ... IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain t... Class II Carl Zeiss Meditec AG
Oct 27, 2015 IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 ... IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain t... Class II Carl Zeiss Meditec AG
Jan 22, 2015 FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3... Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of t... Class II Carl Zeiss Meditec AG
Feb 3, 2014 Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured b... Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. Class II Carl Zeiss Meditec AG
Oct 23, 2013 Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Oct 23, 2013 Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, 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.