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 |
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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