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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.