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Draeger, Inc.

21 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Atlan A350. Model Number: 8211500. anesthesia workstation recall (Z-2207-2026)Draeger, Inc.2026-06-04
Atlan A350XL. Model Number: 8621600. anesthesia workstation recall (Z-2208-2026)Draeger, Inc.2026-06-04
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. recall (Z-0933-2026)Draeger, Inc.2025-12-23
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. recall (Z-0934-2026)Draeger, Inc.2025-12-23
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respirator recall (Z-0590-2026)Draeger, Inc.2025-12-08
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respirat recall (Z-0591-2026)Draeger, Inc.2025-12-08
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respirat recall (Z-0592-2026)Draeger, Inc.2025-12-08
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respirat recall (Z-0593-2026)Draeger, Inc.2025-12-08
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: recall (Z-2616-2025)Draeger, Inc.2025-10-01
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Versio recall (Z-2617-2025)Draeger, Inc.2025-10-01
SafeStar 90 Plus Filter. Bidirectionally breathing system filter. recall (Z-2158-2025)Draeger, Inc.2025-07-31
SafeStar 55 Plus Filter. Bidirectionally breathing system filter. recall (Z-2159-2025)Draeger, Inc.2025-07-31
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. recall (Z-2160-2025)Draeger, Inc.2025-07-31
SafeStar 60A Plus Filter. Bidirectionally breathing system filter. recall (Z-2161-2025)Draeger, Inc.2025-07-31
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Softwar recall (Z-1493-2025)Draeger, Inc.2025-04-03
Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Sof recall (Z-1494-2025)Draeger, Inc.2025-04-03
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catal recall (Z-1495-2025)Draeger, Inc.2025-04-03
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catal recall (Z-1496-2025)Draeger, Inc.2025-04-03
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catal recall (Z-1497-2025)Draeger, Inc.2025-04-03
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Ca recall (Z-1498-2025)Draeger, Inc.2025-04-03
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Cat recall (Z-1499-2025)Draeger, Inc.2025-04-03

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Every clearance here is in the API, with alerts when new ones post.