Draeger Medical, Inc.

Complete recall history across all FDA and CPSC categories — 78 total recalls

Draeger Medical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (78)

FDA medical device enforcement actions by Draeger Medical, Inc.. Showing most recent 50.

Date Product Reason Class
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 ven... Class I
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 ven... Class I
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 ven... Class I
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 ven... Class I
Mar 20, 2024 Dr¿ger Perseus A500 Anesthesia Workstation Unexpected shutdown while operating on battery power. Class I
Jul 12, 2023 Carina Sub-Acute Care Ventilator Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropa... Class I
Jun 12, 2023 Oxylog 3000 Plus emergency and transport ventilator Draeger has become aware of instances where the device stopped working when i... Class I
Apr 17, 2023 ID Coax 180, MP03375 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Coax (P) 150, MP00379 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Watertrap (P) 180 w/oLL, MP00362 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Bag Set (N) 110, MP00383 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Ventstar Coax 230, MP03376 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Anesthesia Circuit Kit Coax HEPA, MP17102 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar breathing bag Set (P) 110, MP00384 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Basic (N) 180, MP00353 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Anesthesia Circuit Kit Coax 1, MP02730 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Ventstar Coax 180, MP03374 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Anesthesia Circuit Kit Coax 3, MP02732 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Basic (P)250, MP00352 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 ID Circuit Basic (P) 180, MP01340 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Ventstar Coax, MP03373 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Anesthesia (N) 180, MP00333 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Watertrap (P) 180, MP00361 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Watertrap (N) 180, MP00363 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Anesthesia Set Coax 180, MP03384 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Anesthesia WT (P)180, MP00374 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Seattle PAP Plus, MP02260 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 Set2Go Ventilation 12 (A), MP07968 Glued connections of the breathing circuit can become loose before or during ... Class I
Apr 17, 2023 VentStar Basic (P)180, MP00351 Glued connections of the breathing circuit can become loose before or during ... Class I
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 im... Class I
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 im... Class I
May 16, 2022 Drager SafeStar 55, Catalog No. MP01790 Possible occlusion of filters due to manufacturing error. Class I
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 securit... Class II
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 securit... Class II
Dec 16, 2021 Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 26 Fabius MRI Anesthesia machines were distributed with internal hoses routin... Class II
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 ... Class II
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 ... Class II
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 ... Class II
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 ... Class II
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 ... Class II
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 ... Class II
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... Class II
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... Class II
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... Class II
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... Class II
Dec 21, 2018 VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/... Incorrectly pre-assembled breathing circuit has potential for incorrect conne... Class I
Dec 21, 2018 ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesi... Incorrectly pre-assembled breathing circuit has potential for incorrect conne... Class I
Dec 21, 2018 VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthe... Incorrectly pre-assembled breathing circuit has potential for incorrect conne... Class I
Dec 21, 2018 VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia ... Incorrectly pre-assembled breathing circuit has potential for incorrect conne... Class I
Dec 21, 2018 VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthe... Incorrectly pre-assembled breathing circuit has potential for incorrect conne... Class I

View all 78 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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