Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Ster... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Emb... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 Monaco Radiation Treatment Planning System (RTP) System Monaco is using the incorrect energy when optimizing and calculating dose. Class II Elekta Inc
Nov 22, 2019 MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolizatio... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 . The abutment provided with the Implant System may be out of specification, which could lead to a ... Class II Zest Anchors LLC
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Emb... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 21, 2019 The products involved are DeWALT laser distance measurers, model numbers DW01... The products are labeled as Class II lasers. However, the level of laser radiation emitted by the... Class II STANLEY BLACK & DECKER INC.
Nov 21, 2019 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1... While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advan... Class II 3M Company - Health Care Business
Nov 21, 2019 ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): ... The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcompone... Class II Radiometer Medical ApS
Nov 21, 2019 Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - P... Pin To Rod Coupling could not clamp the pin and rod as intended Class II Stryker GmbH
Nov 21, 2019 DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3... The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. Class II DeRoyal Industries Inc
Nov 21, 2019 CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeS... Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared... Class II Caire, Inc.
Nov 21, 2019 Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R052... The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcompone... Class II Radiometer Medical ApS
Nov 20, 2019 Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is ... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 20, 2019 Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It i... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 20, 2019 Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Safeline Y-Type Blood Set, Catalog Number NF5140 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Safeline Y-Type Blood Set, Catalog Number V2500 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 20, 2019 ProxiDiagnost N90 Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. Class II Philips North America, LLC
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490314 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490530 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490293 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490425 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 19, 2019 Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Ver... It was reported that the user's low alarm feature on the iOS application were not properly alert... Class II Dexcom Inc
Nov 19, 2019 TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product ... The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. Class II Cardiac Assist, Inc
Nov 19, 2019 MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated ... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo ... Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... Class I Philips Respironics, 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.