Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-18... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. Screws mounting an internal power supply may come loose during shipping resulting in increased ri... Class II Myolyn Inc.
Jul 19, 2022 VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: ... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jul 19, 2022 NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... Class III NuVasive Inc
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-1... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 18, 2022 BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Dr... Incorrect expiration date listed on the product labels. The expiration date listed on the product... Class II Becton Dickinson & Company
Jul 18, 2022 Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for... Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potentia... Class II Siemens Healthcare Diagnostics, Inc.
Jul 15, 2022 (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity ... Inaccurate Distance and Area measurements with use of Global Stack viewport. Class II GE Healthcare, LLC
Jul 15, 2022 DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release... The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap... Class II DeRoyal Industries Inc
Jul 15, 2022 Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmenta... Potential for the incorrect screw to be included in the package. Class II Aesculap Implant Systems LLC
Jul 14, 2022 EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System Update to IFU provides a manual deployment workaround method to help mitigate potential harms rel... Class II Medtronic Inc.
Jul 14, 2022 ARIES SARS-CoV-2 Assay SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A pos... Class II Luminex Corporation
Jul 14, 2022 cobas e801 Immunoassay Analyzer Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2022 Philips EPIQ Ultrasound Systems (various models) used in conjunction with th... Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to tra... Class II Philips Ultrasound, LLC
Jul 14, 2022 Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recov... Class II Aesculap Implant Systems LLC
Jul 14, 2022 The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Cor... There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. Class II Baxter Healthcare Corporation
Jul 13, 2022 Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-... Suture anchor may break upon insertion, which could lead to potential debris in patient, and dela... Class II Paragon 28, Inc.
Jul 13, 2022 ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number S... MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case ... Class II Materialise USA LLC
Jul 13, 2022 VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... There are 7 reported software anomalies that may affect use of the device. Class II bioMerieux, Inc.
Jul 12, 2022 TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Ce... Some of the devices did not pass fatigue testing. Class II Corin Ltd
Jul 12, 2022 HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1 Distributed VTM outside of VTM Guidance and without clearance. Class I Haimen Shengbang Laboratory Equipment Co. Ltd.
Jul 12, 2022 Surpria: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... Class II FUJIFILM Healthcare Americas Corporation
Jul 12, 2022 HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made Distributed VTM outside of VTM Guidance and without clearance. Class I Haimen Shengbang Laboratory Equipment Co. Ltd.
Jul 12, 2022 HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Act... Distributed VTM outside of VTM Guidance and without clearance. Class I Haimen Shengbang Laboratory Equipment Co. Ltd.
Jul 12, 2022 SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... Class II FUJIFILM Healthcare Americas Corporation
Jul 12, 2022 Surpria 64: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... Class II FUJIFILM Healthcare Americas Corporation
Jul 12, 2022 AXIOM Sensis or Sensis Vibe Combo systems as follows: System ... The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the ... Class III Siemens Medical Solutions USA, Inc
Jul 11, 2022 NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Par... Due to a defect identified on the EPG controller printed circuit board assembly, device performan... Class I Synapse Biomedical Inc
Jul 11, 2022 SafeControl handset (a component of the Sentida bed which moves and positions... When the handset is disconnected from the power mains, and mains operation is restored, the hands... Class II WISSNER-BOSSERHOFF GMBH
Jul 10, 2022 INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantabl... Higher than expected flow rate. Class I Intera Oncology, Inc.
Jul 8, 2022 Pentacam HR REF 70900. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 8, 2022 Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 8, 2022 Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior... Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 7, 2022 The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the Z... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 7, 2022 The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 7, 2022 AIM-V Medium REF AV.200/500 Due to equipment failure, affected products were stored at temperatures outside the validated ran... Class II OXFORD IMMUNOTEC LTD
Jul 7, 2022 The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 7, 2022 T-SPOT.TB REF TB.300 US Due to equipment failure, affected products were stored at temperatures outside the validated ran... Class II OXFORD IMMUNOTEC LTD
Jul 7, 2022 T-Cell Xtend REF TTK.610 US Due to equipment failure, affected products were stored at temperatures outside the validated ran... Class II OXFORD IMMUNOTEC LTD
Jul 7, 2022 ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S Mis-wired component-the improperly wired component can result in additional noise on the power su... Class II Olympus Corporation of the Americas
Jul 5, 2022 ZAP-X Radiosurgery System Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to ... Class II Zap Surgical Systems
Jul 4, 2022 Medicina Reusable Oral syringe 1ml Code: OTH01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Reusable Oral syringe 2.5ml Code: OTH25 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Oral Tip Syringe 1ml Code: OT01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd
Jul 4, 2022 Medicina Reusable Oral syringe 5ml Code: OTH05 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... Class II Medicina Uk Ltd

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.