Draeger Medical Systems, Inc.

Complete recall history across all FDA and CPSC categories — 12 total recalls

Draeger Medical Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (12)

FDA medical device enforcement actions by Draeger Medical Systems, Inc.

Date Product Reason Class
Jan 14, 2025 Infinity Central Station. Model Number: MS26800 The Infinity CentralStatio... Edifier speakers (shipped in or after April 2023) may not annunciate when con... Class II
May 13, 2024 Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power... Device is not in full compliance to Type CF requirements of IEC 60601-1 and I... Class II
May 16, 2023 Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s)... The Resuscitaire Infant Radiant Warmer with the optional scale could display ... Class II
Apr 5, 2023 Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia... The software on the Infinity CentralStation drops peaks on narrow waveforms c... Class II
Apr 5, 2023 Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and puls... The software on the Infinity CentralStation drops peaks on narrow waveforms c... Class II
May 20, 2022 Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509... The firm has initiated this recall to replace component on devices distribute... Class II
May 15, 2018 Draeger Jaundice Meter JM-105 The device is intended for use in hospitals,... Users have misinterpreted the display for out of range measurement indicated ... Class I
May 15, 2018 Draeger Jaundice Meter JM-103 The device is intended for use in hospitals... Users have misinterpreted the display for out of range measurement indicated ... Class I
Mar 5, 2014 Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Par... The potentiometers (knobs) for setting the ventilation parameters may have co... Class I
Feb 7, 2014 Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care... The battery capacity of the optional PS500 Power Supply Unit of the Infinity ... Class I
Dec 10, 2013 Draeger Infinity Acute Care System Monitoring Solution After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo... Class II
Jul 2, 2012 Drager PT 4000 Phototherapy System A routine internal quality check found that the Drager PT 4000 Phototherapy S... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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