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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Date	Product	Reason	Class	Firm
Oct 30, 2020	Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respirat...	Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization...	Class II	Invacare Corporation
Oct 30, 2020	Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten...	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is...	Class II	Respironics California, LLC
Oct 30, 2020	Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte...	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is...	Class II	Respironics California, LLC
Oct 30, 2020	Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023	Potential for a false-negative result.	Class II	Luminex Corporation
Oct 30, 2020	Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int...	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is...	Class II	Respironics California, LLC
Oct 30, 2020	Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: ...	Potential for a false-negative result.	Class II	Luminex Corporation
Oct 30, 2020	Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ...	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is...	Class II	Respironics California, LLC
Oct 30, 2020	DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); ac...	The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be misl...	Class II	Neocis, Inc.
Oct 30, 2020	Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten...	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is...	Class II	Respironics California, LLC
Oct 30, 2020	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number:...	Potential for a false-negative result.	Class II	Luminex Corporation
Oct 30, 2020	Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten...	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is...	Class II	Respironics California, LLC
Oct 30, 2020	Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten...	Ventilator may experience potential issues with the backup battery failures: 1) if the battery is...	Class II	Respironics California, LLC
Oct 29, 2020	PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Co...	There is a potential that catheters may have incorrectly marked balloon and arterial lines. Th...	Class II	Prytime Medical Devices, Inc.
Oct 29, 2020	MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Produc...	Control lots may not meet stability criteria and could result in increased results of patient sam...	Class II	Chromsystems Instruments & Chemicals GmbH
Oct 29, 2020	MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Produ...	Control lots may not meet stability criteria and could result in increased results of patient sam...	Class II	Chromsystems Instruments & Chemicals GmbH
Oct 29, 2020	6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order N...	Calibrator lots may not meet stability criteria and could result in increased results of patient ...	Class II	Chromsystems Instruments & Chemicals GmbH
Oct 27, 2020	MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspi...	Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unint...	Class II	Mani, Inc. - Kiyohara Facility
Oct 27, 2020	MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate o...	Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unint...	Class II	Mani, Inc. - Kiyohara Facility
Oct 27, 2020	All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, E...	The manufacturer has determined that with certain uncommon workflows there is potential for incor...	Class II	Philips Ultrasound Inc
Oct 27, 2020	MAC VU360, Electrocardiograph	Incorrect patient identification and/or patient demographic errors.	Class II	GE Healthcare, LLC
Oct 26, 2020	Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers d...	Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef b...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 26, 2020	Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers d...	Test Definition scanning may reset custom settings to defaults causing falsely low or high result...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 23, 2020	Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, ...	Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball...	Class II	Medtronic Heart Valves Division
Oct 23, 2020	PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm	The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a cus...	Class II	Ethicon, Inc.
Oct 23, 2020	BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administ...	Product shelf cartons incorrectly labeled as products intended for the Latin American market. Alt...	Class II	Becton Dickinson & Company
Oct 23, 2020	VGlove NITRILE *** Protect Your Life 100 Patient examination gloves	Package labeled as nitrile gloves, contains latex gloves.	Class II	HUBO INTERNATIONAL INC
Oct 23, 2020	Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS...	Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball...	Class II	Medtronic Heart Valves Division
Oct 23, 2020	The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnost...	The firm has become aware of nine reports by a single customer that the software made false posit...	Class II	Biomeme, Inc.
Oct 23, 2020	Titan Pump - Product Usage: indicated for male patients suffering from erecti...	Potential increased occurrence of pump fracture over the lifetime of the device.	Class II	Coloplast Manufacturing US, LLC
Oct 23, 2020	Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tub...	There is a potential for contamination within Viral Transport Media. Use of contaminated Viral T...	Class II	Hardy Diagnostics
Oct 23, 2020	Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usag...	The distal tip ring of the fully articulating catheter may become dislodged during the procedure.	Class II	Intuitive Surgical, Inc.
Oct 23, 2020	Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-...	Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball...	Class II	Medtronic Heart Valves Division
Oct 23, 2020	Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Softw...	Stryker has discovered a characterization issue associated with the Mako Integrated Cutting Syste...	Class II	Mako Surgical Corporation
Oct 22, 2020	Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved...	Affected product was dropped during manufacturing, which may result in a bent wire guide and/or t...	Class I	Cook Inc.
Oct 21, 2020	Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluo...	Some electronic components within the generator were equipped with an incorrect protection diode....	Class II	Siemens Medical Solutions USA, Inc
Oct 20, 2020	Strauss 25 Carbide Dental Burs (100057XXV)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	Clinic Pack 100 Pieces FG 57 100057C (100057C)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	Alpen Clinic 100 Carbide Instruments (R100057C)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	FG 57 100057X (100057X)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	CEI Cutting Edge Instruments (PTC-57C)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 38...	There is a potential that components of the receive coil can reach elevated temperatures which ha...	Class II	Viewray, Inc.
Oct 20, 2020	ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 ...	There is a potential that components of the receive coil can reach elevated temperatures which ha...	Class II	Viewray, Inc.
Oct 19, 2020	Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral fo...	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t...	Class II	Geistlich Pharma North America, Inc.
Oct 19, 2020	Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for...	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t...	Class II	Geistlich Pharma North America, Inc.
Oct 19, 2020	MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage:...	Treatment beam information disappears on Treatment Console screen while beam delivery continues p...	Class II	Mevion Medical Systems, Inc.
Oct 19, 2020	Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for fi...	Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t...	Class II	Geistlich Pharma North America, Inc.
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used fo...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: us...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas
Oct 16, 2020	VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use...	Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verif...	Class III	Ortho Clinical Diagnostics Inc
Oct 16, 2020	Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used wi...	A new inspection step was added to the cleaning and disinfection section of the Instructions For ...	Class II	Olympus Corporation of the Americas

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.