Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Nov 19, 2020 DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgi... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgic... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Produ... The expiration date on labeling is incorrect. Class II Lidco Ltd
Nov 19, 2020 DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... Class I Heartware, Inc.
Nov 19, 2020 DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 Emission Computed Tomography System Image Process System - Product Usage: int... A software defect that has the potential to result in image misdiagnosis and incorrect treatment ... Class II Philips North America, LLC
Nov 19, 2020 DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 The cobas z 480 analyzer including dedicated software for IVD use is a plate-... Dirty Lens May Cause Invalid or False Positive Results Class II Roche Molecular Systems, Inc.
Nov 19, 2020 Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ... A software anomaly in the A620 Patient Programmer application was identified that results in fail... Class II Medtronic Neuromodulation
Nov 19, 2020 DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrumen... STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseu... Class II Steris Corporation
Nov 19, 2020 DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 18, 2020 ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle... Class II Aesculap Implant Systems LLC
Nov 18, 2020 IceSphere" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usa... Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... Class II Philips North America Llc
Nov 18, 2020 IceRod" 1.5 MRI 90¿ Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" He-Thaw Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 PLUS Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usag... BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2... Class II Becton Dickinson & Company
Nov 18, 2020 Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 18, 2020 IceSphere" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Three IceFORCE" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 MRI Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Three IcePearl" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended fo... Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... Class II Philips North America Llc
Nov 18, 2020 IceSeed" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceEDGE" 2.4¿ 90p¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation

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.