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Browse Device Recalls

78 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 78 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 78 FDA device recalls.

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DateProductReasonClassFirm
Oct 15, 2024 Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 ... The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... Class I Draeger Medical, Inc.
Oct 15, 2024 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... Class I Draeger Medical, Inc.
Oct 15, 2024 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... Class I Draeger Medical, Inc.
Oct 15, 2024 Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 862140... The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... Class I Draeger Medical, Inc.
Mar 20, 2024 Dr¿ger Perseus A500 Anesthesia Workstation Unexpected shutdown while operating on battery power. Class I Draeger Medical, Inc.
Jul 12, 2023 Carina Sub-Acute Care Ventilator Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed t... Class I Draeger Medical, Inc.
Jun 12, 2023 Oxylog 3000 Plus emergency and transport ventilator Draeger has become aware of instances where the device stopped working when in use when transitio... Class I Draeger Medical, Inc.
Apr 17, 2023 ID Coax 180, MP03375 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Coax (P) 150, MP00379 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180 w/oLL, MP00362 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Bag Set (N) 110, MP00383 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax 230, MP03376 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax HEPA, MP17102 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar breathing bag Set (P) 110, MP00384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (N) 180, MP00353 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax 1, MP02730 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax 180, MP03374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax 3, MP02732 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (P)250, MP00352 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 ID Circuit Basic (P) 180, MP01340 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax, MP03373 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Anesthesia (N) 180, MP00333 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180, MP00361 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (N) 180, MP00363 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Set Coax 180, MP03384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Anesthesia WT (P)180, MP00374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Seattle PAP Plus, MP02260 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Set2Go Ventilation 12 (A), MP07968 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (P)180, MP00351 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Jan 23, 2023 NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S)... The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... Class I Draeger Medical, Inc.
Jan 23, 2023 NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP0... The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... Class I Draeger Medical, Inc.
May 16, 2022 Drager SafeStar 55, Catalog No. MP01790 Possible occlusion of filters due to manufacturing error. Class I Draeger Medical, Inc.
Feb 14, 2022 Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ve... Cybersecurity Improvement Action-not equipped against potential cyber security threats Class II Draeger Medical, Inc.
Feb 14, 2022 Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the vent... Cybersecurity Improvement Action-not equipped against potential cyber security threats Class II Draeger Medical, Inc.
Dec 16, 2021 Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxyg... Class II Draeger Medical, Inc.
Sep 10, 2021 Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ... Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... Class II Draeger Medical, Inc.
Sep 10, 2021 Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for t... Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... Class II Draeger Medical, Inc.
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Us... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Us... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Jan 29, 2021 VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Numbe... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Jan 29, 2021 VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Jan 29, 2021 VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Nu... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Jan 29, 2021 ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Numb... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Dec 21, 2018 VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesi... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthe... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia ... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthe... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, 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.