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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Mar 15, 2012 Sunquest Laboratory Sunquest Laboratory is intended for use by professiona... Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, ... Class II Sunquest Information Systems, Inc.
Dec 5, 2011 Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4... Class II Sunquest Information Systems, Inc.
Nov 15, 2011 Sunquest Laboratory : intended for use by professionals working in a clini... Online calculations may not be performed as expected or may yield results that are different than... Class III Sunquest Information Systems, Inc.
Nov 3, 2011 Sunquest Laboratory, version 7.0 not available Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-c... Class II Sunquest Information Systems, Inc.
Aug 12, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage... In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the access... Class III Sunquest Information Systems, Inc.
Apr 28, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select In Online Entry (OEx) there are two scenarios where a Test result from one container may file to ... Class III Sunquest Information Systems, Inc.
Oct 5, 2010 Sunquest Laboratory LabAccess Results Workstation (LARS) The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Re... Class II Sunquest Information Systems, Inc.
Nov 19, 2009 Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface,... The recall was initiated because Sunquest Information System has confirmed reports of an Outbound... Class II Sunquest Information Systems, Inc.
Apr 13, 2009 Sunquest Encompass The reporting site is using the Encompass software in a... Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect ... Class III Sunquest Information 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.