Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of DrägerwerkLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Draeger, Inc. with 22 device recalls. The most recent is a device recall dated Sep 3, 2026: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breat….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 3, 2026 | VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.Class I · Potential cracks in the hose, which could lead to leakage or the hose falling off. | Device recalls |
| May 7, 2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstationClass I · The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of | Device recalls |
| May 7, 2026 | Atlan A350. Model Number: 8211500. anesthesia workstationClass I · The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of | Device recalls |
| Nov 24, 2025 | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.Class I · A certain component of affected devices was not delivered within specification and contained impurities. | Device recalls |
| Nov 24, 2025 | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.Class I · A certain component of affected devices was not delivered within specification and contained impurities. | Device recalls |
| Nov 10, 2025 | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system andClass I · Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Device recalls |
| Nov 10, 2025 | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and Class I · Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Device recalls |
| Nov 10, 2025 | ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and theClass I · Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
