FDA recall record · openFDA

Draeger Medical Systems, Inc.

5 FDA recalls on record (2023–2025) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Fr 2

Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there i 1

Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to de 1

The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. 1

Recalls

Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitor Class II 2025-01-14 Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 Class II 2024-05-13 Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory Class II 2023-04-05 Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1 Class II 2023-05-16 Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the h Class II 2023-04-05

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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