Recall Register

Food, drugs, devices › Firms

Draeger, Inc.

FDA recalling firm · 6 enforcement events · 21 product records · 2025–2026 · PA

Draeger, Inc. has 6 FDA enforcement events on this register (21 product records) between 2025 and 2026: 6 device; the busiest year was 2025 with 5.

100% of its events are Class I; the most common class is Class I (6). 6 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
7 May 2026Atlan A350. Model Number: 8211500. anesthesia workstationDeviceClass I2Ongoing
24 Nov 2025Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.DeviceClass I2Ongoing
10 Nov 2025ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.DeviceClass I4Ongoing
9 Sep 2025Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation,…DeviceClass I2Ongoing
16 Jun 2025SafeStar 90 Plus Filter. Bidirectionally breathing system filter.DeviceClass I4Ongoing
12 Mar 2025Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not…DeviceClass I7Ongoing

By type and class

Device6
Class I6

Class I: 100% of this firm's events; 18% of all events on the register.

Events by year

25
26
Enforcement events for Draeger, Inc. by year initiated.

Questions and answers

How many FDA recalls has Draeger, Inc. had?

6 enforcement events (21 product records) on this register, 2025–2026: 6 device.

Are any Draeger, Inc. recalls ongoing?

6 events are listed as ongoing in the current openFDA export.

What class are Draeger, Inc. recalls?

6 Class I. 100% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.