Browse Device Recalls

48 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 48 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 48 FDA device recalls.

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DateProductReasonClassFirm
Jan 15, 2025 Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a componen... Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... Class I Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... Class II Getinge Usa Sales Inc
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales Inc
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales Inc
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales Inc
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
Dec 11, 2023 Flow-i C40 Anesthesia System, model 6677400 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-i C30 Anesthesia System, model 6677300 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-e Anesthesia System, model 6887900 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-i C20 Anesthesia System, model 6677200 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-c Anesthesia System, model 6887700 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales 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
Sep 6, 2023 Meera Mobile Operating Table-to support and position the patient immediately ... Under certain conditions, an issue might prevent the device from performing as intended. A specif... Class II Getinge Usa Sales Inc
Dec 22, 2022 Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, ... Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... Class I Getinge Usa Sales Inc
Dec 22, 2022 Getinge Flow-c Anesthesia System, Part No. 6887700 Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... Class I Getinge Usa Sales Inc
Dec 22, 2022 Getinge Flow-e Anesthesia System, Part No. 6887900 Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... Class I Getinge Usa Sales Inc
Nov 7, 2022 Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Pr... The power backup battery, under certain conditions, may exhibit reduced battery run-time while in... Class II Getinge Usa Sales Inc
Oct 14, 2022 Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and ... The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a pa... Class II Getinge Usa Sales Inc
Jul 21, 2022 Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for ... Device does not meet regulatory requirements of stability while stationary, which requires mechan... Class II Getinge Usa Sales Inc
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
May 6, 2022 VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600... Paint particles may detach and fall in the operating field. In the worst case scenario, infection... Class II Getinge Usa Sales Inc
May 2, 2022 Flow-e Anesthesia System : Intended for use in administering anesthesia while... Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... Class I Getinge Usa Sales Inc
May 2, 2022 Flow-c Anesthesia System : intended for use in administering anesthesia whil... Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... Class I Getinge Usa Sales Inc
Apr 13, 2022 Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-cham... Verification of installation not documented or may be incomplete, could result in harm to the use... Class II Getinge Usa Sales Inc
Apr 13, 2022 Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washe... Verification of installation not documented or may be incomplete, could result in harm to the use... Class II Getinge Usa Sales Inc
Apr 1, 2022 Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 91... Inadequate documentation verifying whether device installation has been executed in accordance wi... Class II Getinge Usa Sales Inc
Dec 9, 2021 Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the fo... A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) h... Class I 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.