Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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Date	Product	Reason	Class	Firm
Nov 10, 2023	48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of stric...	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a...	Class II	Olympus Corporation of the Americas
Nov 10, 2023	EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of ...	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a...	Class II	Olympus Corporation of the Americas
Nov 10, 2023	EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of str...	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a...	Class II	Olympus Corporation of the Americas
Nov 8, 2023	Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Missi...	The internal diameter of the coaxial cannula may be smaller or larger than the external diameter ...	Class II	Bard Peripheral Vascular Inc
Nov 8, 2023	Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD ...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - A...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and P...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AX...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E -...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light S...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF ...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Ca...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numb...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 8, 2023	Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Cata...	A potential for a light system to fall in the operating room.	Class II	Getinge Usa Sales Inc
Nov 7, 2023	Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, ...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introd...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cul...	Potentially defective utility trays in the reagent kits.	Class II	Luminex Corporation
Nov 7, 2023	Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are ...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822...	Firm received reports of customers experiencing noise from the NIM System, lead-off or high imped...	Class II	Medtronic Xomed, Inc.
Nov 7, 2023	The System is designed as a modular system with components that include an Ov...	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain...	Class II	GE Hangwei Medical Systems, Co. LTD
Nov 7, 2023	Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introdu...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	Navik 3D v2, REF NAVIK3D, 3D Mapping System	IFU update	Class III	APN Health LLC
Nov 7, 2023	Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introdu...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introdu...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	The System is designed as a modular system with components that include an Ov...	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain...	Class II	GE Hangwei Medical Systems, Co. LTD
Nov 7, 2023	Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 7, 2023	Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040,...	Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the...	Class II	Abiomed, Inc.
Nov 6, 2023	SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assa...	A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when ...	Class III	Randox Laboratories Ltd.
Nov 6, 2023	Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY	The sterility of microcatheter and infusion system devices cannot be guaranteed.	Class II	Merit Medical Systems, Inc.
Nov 6, 2023	Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides he...	It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi...	Class II	Sarnova HC, Llc
Nov 6, 2023	Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A ...	Reports of a pink or green coloration of the image. If the issue is encountered during a procedur...	Class II	Olympus Corporation of the Americas
Nov 6, 2023	0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100M...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID ...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SY...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10M...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxid...	Certain factory settings for the device were incorrectly described in the IFU-related to the warn...	Class II	Maquet Medical Systems USA
Nov 6, 2023	Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 2...	The sterility of microcatheter and infusion system devices cannot be guaranteed.	Class II	Merit Medical Systems, Inc.
Nov 6, 2023	AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 1114...	AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the ...	Class II	Physio-Control, Inc.
Nov 6, 2023	Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Ite...	It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi...	Class II	Sarnova HC, Llc
Nov 6, 2023	Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/...	The sterility of microcatheter and infusion system devices cannot be guaranteed.	Class II	Merit Medical Systems, Inc.
Nov 3, 2023	PVP SOLUTION SING STRL, REF DYNDA1858	The product description on the labeling includes the word "Sterile" or STRL", however the content...	Class II	MEDLINE INDUSTRIES, LP - Northfield

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.