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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 12 FDA device recalls.

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DateProductReasonClassFirm
Jan 14, 2025 Infinity Central Station. Model Number: MS26800 The Infinity CentralStatio... Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mo... Class II Draeger Medical Systems, Inc.
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 IEC 60601-2-34 standa... Class II Draeger Medical Systems, Inc.
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 inaccurate weight va... Class II Draeger Medical Systems, Inc.
Apr 5, 2023 Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia... The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... Class II Draeger Medical Systems, Inc.
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 causing the Infinity ... Class II Draeger Medical Systems, Inc.
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 distributed containing a compo... Class II Draeger Medical Systems, Inc.
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 by the blinking "-... Class I Draeger Medical Systems, Inc.
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 by the blinking" ... Class I Draeger Medical Systems, Inc.
Mar 5, 2014 Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Par... The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted an... Class I Draeger Medical Systems, Inc.
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 ACS Workstation Crit... Class I Draeger Medical Systems, Inc.
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-natal mode and was ... Class II Draeger Medical Systems, Inc.
Jul 2, 2012 Drager PT 4000 Phototherapy System A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with... Class II Draeger Medical Systems, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.