Draeger recalls
Draeger appears in 22 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 22 |
|---|---|
| Published | 2025-04-09 to 2026-10-07 |
| By agency | FDA Device (22) |
| By classification | Class I (22) |
| By status | ongoing (22) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, ND, NE, NM, NV, NY, OH, OK, PA, SC, SD, TX, US, UT, VA, WI |
Recalls
- VentStar Resus Neo
FDA Device · Class I · 2026-10-07 · Draeger
Reason: Potential cracks in the hose, which could lead to leakage or the hose falling off. - Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Device · Class I · 2026-06-10 · Draeger
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - Atlan A350
FDA Device · Class I · 2026-06-10 · Draeger
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - Draeger Vapor 2000
FDA Device · Class I · 2025-12-31 · Draeger
Reason: A certain component of affected devices was not delivered within specification and contained impurities. - Draeger Vapor 3000
FDA Device · Class I · 2025-12-31 · Draeger
Reason: A certain component of affected devices was not delivered within specification and contained impurities. - ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the pa…
FDA Device · Class I · 2025-12-17 · Draeger
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. - ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the pa…
FDA Device · Class I · 2025-12-17 · Draeger
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. - ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the pa…
FDA Device · Class I · 2025-12-17 · Draeger
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. - ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the pati…
FDA Device · Class I · 2025-12-17 · Draeger
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. - Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is…
FDA Device · Class I · 2025-10-08 · Draeger
Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan…
FDA Device · Class I · 2025-10-08 · Draeger
Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - SafeStar 90 Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. - SafeStar 55 Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. - SafeStar 60A Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. - HME TwinStar HEPA Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger
Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not appli…
FDA Device · Class I · 2025-04-09 · Draeger
Reason: The potential for cracks forming in the breathing circuit hose. - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applic…
FDA Device · Class I · 2025-04-09 · Draeger
Reason: The potential for cracks forming in the breathing circuit hose. - Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Br…
FDA Device · Class I · 2025-04-09 · Draeger
Reason: The potential for cracks forming in the breathing circuit hose. - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicab…
FDA Device · Class I · 2025-04-09 · Draeger
Reason: The potential for cracks forming in the breathing circuit hose. - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicab…
FDA Device · Class I · 2025-04-09 · Draeger
Reason: The potential for cracks forming in the breathing circuit hose. - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicab…
FDA Device · Class I · 2025-04-09 · Draeger
Reason: The potential for cracks forming in the breathing circuit hose. - Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description…
FDA Device · Class I · 2025-04-09 · Draeger
Reason: The potential for cracks forming in the breathing circuit hose.