Browse Device Recalls

740 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 740 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 740 FDA device recalls.

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DateProductReasonClassFirm
Nov 21, 2017 Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilato... Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Benne... Class II Covidien LLC
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
Oct 30, 2017 Plum 360 Infusion System, List number 30010. (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" sta... Class II ICU Medical Inc
Oct 16, 2017 Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: ... For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices... Class II Fukuda Denshi Co., Ltd.
Sep 12, 2017 Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable... Analysis of the difference between the actual device longevity and the battery indicator status p... Class II St. Jude Medical, Inc.
Sep 12, 2017 Proclaim DRG Implantable Pulse Generator Model 3664 Analysis of the difference between the actual device longevity and the battery indicator status p... Class II St. Jude Medical, Inc.
Sep 12, 2017 Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Gener... Analysis of the difference between the actual device longevity and the battery indicator status p... Class II St. Jude Medical, Inc.
Aug 28, 2017 Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... The device may exhibit premature battery depletion. Class I St Jude Medical Inc.
Aug 28, 2017 Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... The device may exhibit premature battery depletion. Class I St Jude Medical Inc.
Jul 14, 2017 TD60 Transmitter battery charger used with the BeneVision Central Station, Pa... A damaged circuit board in the battery charger can cause the battery to overcharge and the batter... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 7, 2017 Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery... The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective ... Class II Ondamed Inc
Jun 12, 2017 Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Bloo... Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... Class II Roche Diabetes Care, Inc.
Jun 12, 2017 Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood G... Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... Class II Roche Diabetes Care, Inc.
Jun 2, 2017 Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Apr 28, 2017 Monica Novii Wireless Patch System product Usage: Novii Interface - The N... Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged cha... Class II MONICA HEALTHCARE LTD
Apr 28, 2017 TI Transport Monitor/Module Battery Pack Product Usage: intended for moni... Mindray has received two reports from outside the United States that the battery pack for TI tran... Class II Mindray DS USA, Inc. dba Mindray North America
Apr 11, 2017 PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 625... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Feb 27, 2017 Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ON... A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 ma... Class II Welch Allyn Inc
Feb 24, 2017 HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536... HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a si... Class I Philips North America, LLC
Feb 15, 2017 Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Caps... When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was d... Class II IntroMedic Co., 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.
Jan 31, 2017 MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... Class II Medtronic Inc.
Dec 30, 2016 Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ... Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,... Class II Hospira Inc., A Pfizer Company
Dec 23, 2016 CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 09... Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CAR... Class II Maquet Datascope Corp - Cardiac Assist Division
Nov 1, 2016 Alaris System PC unit, model no. 8000 and 8015. The central programming, mon... Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered bef... Class II CareFusion 303, Inc.
Oct 25, 2016 SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Ca... Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to th... Class II MED-EL Elektromedizinische Gereate, Gmbh
Oct 19, 2016 Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile ... Products are not designed, qualified, manufactured, and/or managed under a state of control per i... Class II Ultroid Technologies, Inc.
Oct 10, 2016 Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 10, 2016 Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 10, 2016 Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 3, 2016 Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h... Medtronic has identified an increased number of complaints from customers involving reports of Re... Class II Medtronic Neuromodulation
Aug 12, 2016 Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Jul 18, 2016 NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X... Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ... Class II Aribex Inc
Jul 18, 2016 NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged... Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ... Class II Aribex Inc
Jun 24, 2016 Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:... There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 24, 2016 Light Adaptor for Small Battery Drive and Small Battery Drive II. There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
May 5, 2016 Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Powe... Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either t... Class II Stryker Medical Division of Stryker Corporation
May 3, 2016 Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Mod... Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior ... Class II Medtronic Neuromodulation
Apr 13, 2016 Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor... Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used ... Class I Medtronic
Apr 6, 2016 EZ Slide Battery/line powered hydraulic table with removable leg section and ... The potential exists within the identified tables that incorrectly manufactured parts have been u... Class II Skytron, Div. The KMW Group, Inc
Feb 25, 2016 TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high... The firm received a complaint of the battery exploding while recharging. Class II Scottcare Corporation
Feb 23, 2016 Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E... Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC... Class II Medtronic 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.