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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Jul 14, 2017 Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, R... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intende... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is int... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody i... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is in... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is inte... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
May 6, 2016 Ariol is an automated scanning microscope and image analysis system. It is in... An issue during the manufacturing process caused systems to have an improperly activated Windows ... Class III Leica Biosystems Richmond Inc.
May 2, 2016 CytoVision Image Analysis and Capture System, an automated cell-locating devi... Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was asso... Class III Leica Biosystems Richmond 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.