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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Nov 16, 2018 Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Nov 16, 2018 Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Dec 2, 2017 VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Us... Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 ... Class II Cyberonics, Inc
Nov 13, 2017 VNS Therapy Programmer, Model 3000, v1.0 System Certain Model 3000 programming events can result in miscalculation of parameters stored in the Mo... Class II Cyberonics, Inc
Jun 13, 2017 VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... Manufacturing process used to assemble the circuit board may result in some devices experiencing ... Class II Cyberonics, Inc
Jun 13, 2017 VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... Manufacturing process used to assemble the circuit board may result in some devices experiencing ... Class II Cyberonics, Inc
Dec 18, 2015 VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjuncti... Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring ... Class II Cyberonics, Inc
Nov 18, 2015 Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb... Class II Cyberonics, Inc
Oct 7, 2015 Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb... Class II Cyberonics, Inc
Mar 6, 2015 VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Gener... The pulse generators have a lower battery longevity than specified in their design requirement as... Class II Cyberonics, Inc
Nov 20, 2014 Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Ther... The recalled product was distributed with an incorrect serial number printed on the device's label. Class II Cyberonics, 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.