Browse Device Recalls
728 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 728 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 728 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly,... | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from t... | Class I | Insulet Corporation |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 7, 2022 | FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V ... | Batteries could become unstable when not properly maintained and/or subjected to repeated drops, ... | Class II | Ferno-Washington Inc |
| Oct 3, 2022 | Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automate... | Unable to charge the battery pack- battery packs will allow the batteries to be charged if the vo... | Class II | Rebiscan, Inc. |
| Sep 30, 2022 | EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 30, 2022 | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 22, 2022 | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100... | Due to increase in Li-Ion Battery failures | Class II | ZOLL Circulation, Inc. |
| Sep 2, 2022 | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C... | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc... | Class III | Baxter Healthcare Corporation |
| Aug 29, 2022 | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power... | Battery may dislodge from the Power Knee | Class II | Ossur Americas |
| Aug 12, 2022 | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mob... | Due to un-commanded movement of mobile x-ray unit. | Class II | SEDECAL SA |
| Jun 28, 2022 | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1... | Battery performance issues. Battery electrical faults render it unable to power the controller, u... | Class I | Heartware, Inc. |
| Jun 17, 2022 | Merlin PCS 3650 programmer Model 3330 software | There is a potential for programmer software (Merlin PCS) and remote monitoring software applicat... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| May 31, 2022 | Xhibit Telemetry Receiver, Model: 96280 | Software related alarm escalation defect occurs after approximately 25 days of continuous use. Te... | Class II | Spacelabs Healthcare, Inc. |
| May 24, 2022 | Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Int... | It may occur that after system startup no stand movement is possible any longer in the event of a... | Class II | Siemens Medical Solutions USA, Inc |
| May 24, 2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... | Class II | Tandem Diabetes Care Inc |
| May 24, 2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... | Class II | Tandem Diabetes Care Inc |
| May 23, 2022 | MiniMed 630G Insulin Pump (U.S. and Canada Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 620G Insulin Pump (O.U.S. version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 780G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 640G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 720G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 23, 2022 | MiniMed 740G Insulin Pump (O.U.S. Version) | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... | Class II | Medtronic MiniMed |
| May 5, 2022 | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... | Class I | Medtronic Inc |
| Apr 18, 2022 | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 ... | Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... | Class I | GE Healthcare, LLC |
| Apr 18, 2022 | Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Replacement back up batteries distributed on or after April 1, 2019, for CARE... | Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... | Class I | GE Healthcare, LLC |
| Mar 30, 2022 | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V | The battery wiring harness on affected wheelchairs may become disconnected during shipment from t... | Class II | Invacare Corporation |
| Mar 10, 2022 | Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jan 27, 2022 | HeartWare Ventricular Assist Device (HVAD) System | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and B... | Class II | Heartware, Inc. |
| Jan 13, 2022 | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad... | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | Class III | Physio-Control, Inc. |
| Nov 12, 2021 | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusabl... | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a... | Class II | Covidien Llc |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Console" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector USB" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual USB" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Oct 16, 2021 | Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
| Oct 16, 2021 | Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
| Oct 16, 2021 | Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS... | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
| Oct 16, 2021 | Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS... | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
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.