Browse Device Recalls

443 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 443 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 443 FDA device recalls.

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Date	Product	Reason	Class	Firm
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 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 31, 2023	Acrobat-i Vacuum Positioner System, Model Number XP-5000Z	The Positioner Arm may not tighten or lock during normal use.	Class II	Maquet Cardiovascular, LLC
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
Sep 19, 2023	Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri...	Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different...	Class II	Maquet Cardiovascular, LLC
Sep 13, 2023	Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance...	Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epi...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a ches...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a ch...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) P...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
Jun 28, 2023	ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a c...	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil...	Class II	Maquet Cardiovascular, LLC
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
Apr 4, 2023	MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32	The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompati...	Class II	Datascope Corp.
Mar 6, 2023	VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Mar 6, 2023	VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH...	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
Mar 6, 2023	VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000	Some batches of product were not sterilized to their minimum sterilization specification.	Class II	Maquet Cardiovascular, LLC
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
Feb 2, 2023	ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table ...	If, during the procedure, X-ray has been released and a reference image has been stored, the foll...	Class II	Siemens Medical Solutions USA, Inc
Feb 2, 2023	ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET tab...	In the event of any unintended table movement, the system may not detect the incorrect direction,...	Class II	Siemens Medical Solutions USA, Inc
Jan 30, 2023	Fusion Bioline Vascular Graft, Part number M00201503046B0	One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness test...	Class II	Maquet Cardiovascular, LLC
Dec 22, 2022	Hemopro 2 with Vasoshield, Model VH-4001	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t...	Class II	Maquet Cardiovascular, LLC
Dec 22, 2022	Vasoshield Syringe Packs, Model VH-5001	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to t...	Class II	Maquet Cardiovascular, LLC
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
Jul 20, 2022	Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694...	Ventilators may generate a combination of alarms which may result in loss of communication, techn...	Class I	Getinge Usa Sales Inc
Apr 29, 2022	INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovin...	Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm,...	Class II	Maquet Cardiovascular, LLC
Feb 25, 2022	Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUE...	Five potential software issues affecting Artis pheno and Artis icono systems in combination with ...	Class II	Siemens Medical Solutions USA, Inc
Feb 25, 2022	Artis icono biplane- in combination with a Siemens Healthineers table or Tru...	Five potential software issues affecting Artis pheno and Artis icono systems in combination with ...	Class II	Siemens Medical Solutions USA, Inc
Feb 25, 2022	Artis icono floor in combination with a Siemens Healthineers table or Trumpf...	Five potential software issues affecting Artis pheno and Artis icono systems in combination with ...	Class II	Siemens Medical Solutions USA, 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.