Browse Device Recalls

41 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 41 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 41 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 15, 2024	CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.	The firm identified that the measured patient leakage current in some devices significantly excee...	Class II	Maquet Medical Systems USA
Jan 16, 2024	Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 7...	The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du...	Class II	Maquet Medical Systems USA
Jan 16, 2024	BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078....	The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du...	Class II	Maquet Medical Systems USA
Jan 8, 2024	BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70...	Nonconformities at their seal could potentially compromise the sterile barrier for affected produ...	Class II	Maquet Medical Systems USA
Jan 8, 2024	BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70...	Nonconformities at their seal could potentially compromise the sterile barrier for affected produ...	Class II	Maquet Medical Systems USA
Dec 28, 2023	Bubble Sensor (REF: 70105.5720)	The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu...	Class II	Maquet Medical Systems USA
Nov 14, 2023	CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide ...	CARDIOHELP-i System was not properly tested to measure leakage current	Class III	Maquet Medical Systems USA
Nov 13, 2023	Venous probe connection cable (REF 701069333 and 701048804) used with the Car...	Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe con...	Class II	Maquet Medical Systems USA
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
Oct 12, 2023	Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbe...	It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail ...	Class II	Maquet Medical Systems USA
Oct 10, 2023	CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOH...	Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This is...	Class I	Maquet Medical Systems USA
May 18, 2023	HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypas...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary by...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iR, used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass M...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Mo...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iR, used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary by...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
Feb 13, 2023	BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ...	Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. ...	Class II	Maquet Medical Systems USA
Jul 22, 2022	BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Jul 22, 2022	BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Jul 22, 2022	BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Jul 22, 2022	BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A precon...	The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste...	Class II	Maquet Medical Systems USA
Feb 18, 2022	Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood ...	Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of th...	Class II	Maquet Medical Systems USA
Jul 14, 2021	Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water ...	There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ...	Class II	Maquet Medical Systems USA
Oct 5, 2016	Accessory Adapter Part number 600525A0 Product Usage: designed for the mo...	Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 ...	Class II	Maquet Medical Systems USA
Jan 7, 2016	Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, ...	MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension De...	Class II	Maquet Cardiovascular Us Sales, Llc
Aug 21, 2014	TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR In...	The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen ...	Class II	Maquet Medical Systems USA
Apr 16, 2014	Maquet PowerLED 700. Product Usage; To provide illumination to the surgi...	Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or sev...	Class II	Maquet Medical Systems USA
Sep 12, 2013	MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf...	It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device ma...	Class II	Maquet Medical Systems USA

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.