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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Feb 14, 2014 Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Re... Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed ... Class II Spacelabs Healthcare, Llc
Dec 19, 2013 ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 962... The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmit... Class II Spacelabs Healthcare, Llc
Oct 17, 2013 Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. ... Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because t... Class II Spacelabs Healthcare, Llc
Oct 17, 2013 Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a pati... Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incor... Class II Spacelabs Healthcare, Llc
Dec 5, 2012 Spacelabs Smart Disclosure System, Model 92810, is an integrated component of... Displaying or printing of an incorrect waveform for the time indicated in the printout or display... Class II Spacelabs Healthcare, Llc
Oct 19, 2012 qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 ... Spacelabs Healthcare has learned through several reports that the input circuit may fail and the... Class II Spacelabs Healthcare, Llc
Oct 5, 2012 The touchscreen display (model 94267) designed for use with the XPREZZON beds... Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights... Class II Spacelabs Healthcare, Llc
Aug 27, 2012 Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is int... There is a potential failure of the Integrated Module Housing causing the patient module paramete... Class II Spacelabs Healthcare, Llc
Jun 12, 2012 Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with O... There were reports that a certain combination of key presses will cause the module to disconnect ... Class II Spacelabs Healthcare, Llc
May 11, 2012 The product is Pathfinder SL, version 1.6.0.3057 software used with the Space... The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter ... Class II Spacelabs Healthcare, Llc

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.