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Browse Device Recalls

68 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 68 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 68 FDA device recalls.

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DateProductReasonClassFirm
Mar 31, 2016 Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411... St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the... Class II St Jude Medical Inc.
Nov 3, 2015 Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, ... Leads may have been compromised during the manufacturing process, with cuts in the insulation lay... Class I St Jude Medical Cardiac Rhythm Management Division
Feb 11, 2015 Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; ... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Dec 18, 2014 Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software ver... Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jud... Class II St Jude Medical Cardiac Rhythm Management Division
Oct 14, 2014 St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, St... St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" H... Class II St Jude Medical
Oct 14, 2014 St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Mo... St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Re... Class II St Jude Medical
Jul 29, 2014 Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as p... The Directions for Use (DFU) manual contains information for devices that are not approved in the... Class II St. Jude Medical, Inc.
Jul 29, 2014 Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as p... The Directions for Use (DFU) manual contains information for devices that are not approved in the... Class II St. Jude Medical, Inc.
Oct 11, 2013 Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx o... St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... Class II St. Jude Medical
Oct 11, 2013 US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path ... St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... Class II St. Jude Medical
Jan 18, 2013 St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery Sy... The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when... Class I St Jude Medical Inc
Nov 30, 2012 Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 371... There is issues of warmth or heating at the implant site during charging for the Eon Mini implant... Class II St. Jude Medical
Jul 26, 2012 Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated ... St. Jude Medical has informed your doctor that a number of cases have been reported in which disc... Class II St. Jude Medical
Jul 26, 2012 Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: E... St. Jude Medical has informed your doctor that a number of cases have been reported in which disc... Class II St. Jude Medical
Jul 26, 2012 Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the mana... As part of St. Jude Medical's routine tracking and product monitoring, they have received a total... Class II St. Jude Medical
Mar 28, 2012 Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S... St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w... Class III St Jude Medical Inc
Dec 19, 2011 Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be con... As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th... Class II Advanced Neuromodulation Systems Inc.
Dec 19, 2011 The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rech... As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th... Class II Advanced Neuromodulation 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.