Draeger, Inc.

FDA Regulatory Profile

Summary

Total Recalls
19 (19 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0933-2026Class IDraeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.November 24, 2025
Z-0934-2026Class IDraeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.November 24, 2025
Z-0591-2026Class IErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratoryNovember 10, 2025
Z-0593-2026Class IErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratorNovember 10, 2025
Z-0592-2026Class IErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratorNovember 10, 2025
Z-0590-2026Class IErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gaNovember 10, 2025
Z-2617-2025Class IBrand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not September 9, 2025
Z-2616-2025Class IBrand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not apSeptember 9, 2025
Z-2160-2025Class IHME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.June 16, 2025
Z-2158-2025Class ISafeStar 90 Plus Filter. Bidirectionally breathing system filter.June 16, 2025
Z-2159-2025Class ISafeStar 55 Plus Filter. Bidirectionally breathing system filter.June 16, 2025
Z-2161-2025Class ISafeStar 60A Plus Filter. Bidirectionally breathing system filter.June 16, 2025
Z-1494-2025Class IBrand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software VMarch 12, 2025
Z-1498-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog NuMarch 12, 2025
Z-1493-2025Class IBrand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software VersiMarch 12, 2025
Z-1496-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog NumbeMarch 12, 2025
Z-1497-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog NumbeMarch 12, 2025
Z-1499-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog NumMarch 12, 2025
Z-1495-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog NumbeMarch 12, 2025