Drug & Device Safety Atlas

FDA recall record · openFDA

Draeger Medical, Inc.

31 FDA recalls on record (2023–2024) — 31 device. 9 still ongoing.

31
Class I (most serious)
0
Class II
0
Class III
9
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complet 22
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of 4
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as 2
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC 1
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake le 1

Recalls

Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstatio Class I 2024-10-15 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Componen Class I 2024-10-15 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Class I 2024-10-15 Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation Class I 2024-10-15 Dr¿ger Perseus A500 Anesthesia Workstation Class I 2024-03-20 VentStar Basic (P)180, MP00351 Class I 2023-04-17 Set2Go Ventilation 12 (A), MP07968 Class I 2023-04-17 NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L) Class I 2023-01-23 Seattle PAP Plus, MP02260 Class I 2023-04-17 VentStar Anesthesia WT (P)180, MP00374 Class I 2023-04-17 Oxylog 3000 Plus emergency and transport ventilator Class I 2023-06-12 Anesthesia Set Coax 180, MP03384 Class I 2023-04-17 VentStar Watertrap (N) 180, MP00363 Class I 2023-04-17 VentStar Watertrap (P) 180, MP00361 Class I 2023-04-17 VentStar Anesthesia (N) 180, MP00333 Class I 2023-04-17 Ventstar Coax, MP03373 Class I 2023-04-17 NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L) Class I 2023-01-23 ID Circuit Basic (P) 180, MP01340 Class I 2023-04-17 VentStar Basic (P)250, MP00352 Class I 2023-04-17 Anesthesia Circuit Kit Coax 3, MP02732 Class I 2023-04-17 Carina Sub-Acute Care Ventilator Class I 2023-07-12 Ventstar Coax 180, MP03374 Class I 2023-04-17 Anesthesia Circuit Kit Coax 1, MP02730 Class I 2023-04-17 VentStar Basic (N) 180, MP00353 Class I 2023-04-17 VentStar breathing bag Set (P) 110, MP00384 Class I 2023-04-17 Anesthesia Circuit Kit Coax HEPA, MP17102 Class I 2023-04-17 Ventstar Coax 230, MP03376 Class I 2023-04-17 VentStar Bag Set (N) 110, MP00383 Class I 2023-04-17 VentStar Watertrap (P) 180 w/oLL, MP00362 Class I 2023-04-17 VentStar Coax (P) 150, MP00379 Class I 2023-04-17 ID Coax 180, MP03375 Class I 2023-04-17

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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