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
Nov 11, 2020	REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing...	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b...	Class II	Westmed, Inc.
Nov 11, 2020	ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance...	The radio within the device can become disassociated with the wireless access point.	Class II	WELCH ALLYN, INC/MORTARA
Nov 11, 2020	REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 1...	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b...	Class II	Westmed, Inc.
Nov 11, 2020	Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A	A software problem has been identified which could result in the diagnostic imaging system not p...	Class II	Canon Medical System, USA, INC.
Nov 11, 2020	Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001...	The device was assembled with the incorrect exhalation port which can cause gas leakage.	Class II	Intersurgical Inc
Nov 11, 2020	REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect w...	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b...	Class II	Westmed, Inc.
Nov 11, 2020	REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigta...	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b...	Class II	Westmed, Inc.
Nov 11, 2020	(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir,...	Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)	Class II	Terumo Cardiovascular Systems Corporation
Nov 11, 2020	Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for...	Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A20...	Class II	Integra LifeSciences Corp.
Nov 10, 2020	CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a ...	On November 10, 2020, it was discovered that there are post- processing microbial culture test fa...	Class II	CryoLife, Inc.
Nov 10, 2020	AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102...	The products subject to this recall may contain obvious, incorrect pouch labels while the outer b...	Class III	Applied Medical Technology Inc
Nov 10, 2020	PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.	Potential exposure of product to microbial contamination.	Class II	TissueTech, Inc.
Nov 10, 2020	PROKERA, non-sterile - Product Usage: Biologic corneal bandage.	Potential exposure of product to microbial contamination.	Class II	TissueTech, Inc.
Nov 10, 2020	MiniCap Extended Life PD Transfer Set	Potential for no-flow and leaks under the twist clamp.	Class II	Baxter Healthcare Corporation
Nov 10, 2020	CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a ti...	On November 10, 2020, it was discovered that there are post- processing microbial culture test fa...	Class II	CryoLife, Inc.
Nov 10, 2020	PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.	Potential exposure of product to microbial contamination.	Class II	TissueTech, Inc.
Nov 10, 2020	Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit ...	Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ...	Class II	Merit Medical Systems, Inc.
Nov 10, 2020	Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Ste...	Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ...	Class II	Merit Medical Systems, Inc.
Nov 10, 2020	Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Onl...	Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ...	Class II	Merit Medical Systems, Inc.
Nov 9, 2020	Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product...	A software problem has been identified which could result in the CT Scanner not proceeding to th...	Class II	Canon Medical System, USA, INC.
Nov 9, 2020	K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATE...	Due to complaints received associated with cracked/split test tube caps.	Class II	Helena Laboratories, Corp.
Nov 9, 2020	icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo...	Due to a potential software issue, the display may show the incorrect continuous cardiac output (...	Class II	ICU Medical, Inc.
Nov 9, 2020	Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjust...	There is a potential that the adjustable handle option on the X-Ray system may have been installe...	Class II	Shimadzu Medical Systems
Nov 9, 2020	Equinoxe Humeral Stem, Primary, Press Fit, 11mm	Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primar...	Class II	Exactech, Inc.
Nov 9, 2020	Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. ...	Gauze sponges contained in custom kits may be flaking or fraying.	Class II	ROi CPS LLC
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Us...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Us...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Us...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric ...	Product may be missing toric axis marks.	Class II	Bausch & Lomb Surgical, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Us...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Us...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product ...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 7, 2020	NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Us...	The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.	Class II	Fresenius Medical Care Holdings, Inc.
Nov 6, 2020	Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using...	During system upgrade incorrect comments may be added to existing tests. In such instance: Restin...	Class II	Spacelabs Healthcare, Ltd.
Nov 6, 2020	Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usa...	Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the...	Class II	Roche Diagnostics Operations, Inc.
Nov 5, 2020	ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Cat...	Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests	Class II	VEO DIAGNOSTICS, LLC
Nov 5, 2020	RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressin...	RevMedX Trauma Dressing is being recalled due to package seal integrity.	Class II	Medline Industries Inc
Nov 5, 2020	Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization...	Manufacturing error that may have resulted in a cathode component being out of specification. Al...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...

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.