Drug & Device Safety Atlas

FDA recall record · openFDA

Draeger, Inc.

21 FDA recalls on record (2025–2026) — 21 device. 21 still ongoing.

21
Class I (most serious)
0
Class II
0
Class III
21
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

The potential for cracks forming in the breathing circuit hose. 7
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. 4
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. 4
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of 2
A certain component of affected devices was not delivered within specification and contained impurities. 2

Recalls

Atlan A350XL. Model Number: 8621600. anesthesia workstation Class I 2026-05-07 Atlan A350. Model Number: 8211500. anesthesia workstation Class I 2026-05-07 SafeStar 90 Plus Filter. Bidirectionally breathing system filter. Class I 2025-06-16 Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. Class I 2025-11-24 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product De Class I 2025-09-09 Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Class I 2025-03-12 SafeStar 55 Plus Filter. Bidirectionally breathing system filter. Class I 2025-06-16 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Class I 2025-03-12 ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the Class I 2025-11-10 ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the b Class I 2025-11-10 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Class I 2025-09-09 ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the brea Class I 2025-11-10 SafeStar 60A Plus Filter. Bidirectionally breathing system filter. Class I 2025-06-16 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Softwa Class I 2025-03-12 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Class I 2025-03-12 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Class I 2025-03-12 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Softw Class I 2025-03-12 Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. Class I 2025-11-24 ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the Class I 2025-11-10 HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. Class I 2025-06-16 Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicab Class I 2025-03-12

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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