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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DateProductReasonClassFirm
Jan 9, 2026 Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; Internal investigations have identified an issue with the durability of the connecting cable near... Class II Maquet Cardiopulmonary Gmbh
Aug 15, 2025 Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occlu... Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... Class II Maquet Cardiovascular, LLC
Aug 15, 2025 Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occlu... Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... Class II Maquet Cardiovascular, LLC
Aug 15, 2025 Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... Class II Maquet Cardiovascular, LLC
Aug 6, 2025 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ... Reports of out-of-box failures discovered during the limited launch phase. Failure modes included... Class II Maquet Cardiovascular, LLC
Jul 14, 2025 Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001... Under certain conditions, such as the simultaneous use of the operating table with other medical ... Class II MAQUET GMBH
Jun 27, 2025 Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg... Device does not comply with the labeling requirements of international standard IEC 60601-1. Class II Maquet Cardiopulmonary Gmbh
May 30, 2025 Servo-u MR Ventilator System. Model Number: 6888800. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
May 30, 2025 Servo-n Ventilator System. Model Number: 6694800. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
May 30, 2025 Servo-u Ventilator System. Model Number: 6688600. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
Apr 30, 2025 Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the... HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. Class II Maquet Cardiopulmonary Ag
Mar 20, 2025 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... There have been at least 12 complaints from users as of March 3, 2025, reporting that they identi... Class II Maquet Cardiovascular, LLC
Mar 10, 2025 Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of ... Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro ... Class II Maquet Cardiovascular, LLC
Dec 9, 2024 Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model ... Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... Class I Maquet Cardiovascular, LLC
Dec 9, 2024 VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-400... Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... Class I Maquet Cardiovascular, LLC
Oct 16, 2024 Acrobat-i Positioner. Model Number C-XP-5000Z Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... Class II Maquet Cardiovascular, LLC
Oct 16, 2024 Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... Class II Maquet Cardiovascular, LLC
Oct 16, 2024 Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... Class II Maquet Cardiovascular, LLC
Sep 20, 2024 VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W... There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. Class I Maquet Cardiovascular, LLC
May 31, 2024 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... Class II Maquet Cardiovascular, LLC
May 31, 2024 The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use... There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... Class II Maquet Cardiovascular, LLC
May 17, 2024 The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for us... Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... Class II Maquet Cardiovascular, LLC
May 17, 2024 The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo... Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... Class II Maquet Cardiovascular, LLC
May 1, 2024 Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Comp... Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... Class I Getinge Usa Sales Inc
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
Dec 13, 2023 Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... Class I Maquet Cardiovascular, LLC
Dec 13, 2023 Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... Class I Maquet Cardiovascular, LLC
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 1, 2023 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... Class II Maquet Cardiovascular, LLC
Dec 1, 2023 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... Class II Maquet Cardiovascular, LLC
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 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

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.