Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 14, 2017 Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in ... Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine t... Class II Del Mar Reynolds Medical, Ltd.
Feb 8, 2017 Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous... Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting dow... Class II Del Mar Reynolds Medical, Ltd.
Mar 5, 2015 Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacela... Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory ... Class II Del Mar Reynolds Medical, Ltd.
Mar 10, 2014 SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... The System may go into a controlled failed state if a series of parameters on the user interface ... Class I Del Mar Reynolds Medical, Ltd.
Oct 17, 2013 CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation,... Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 a... Class I Del Mar Reynolds Medical, Ltd.
Jun 7, 2013 Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workst... Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer... Class II Del Mar Reynolds Medical, Ltd.
Jan 15, 2013 Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Worksta... A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may caus... Class I Del Mar Reynolds Medical, Ltd.
Nov 2, 2012 BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthe... The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals t... Class II Del Mar Reynolds Medical, Ltd.

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.