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 |
|---|---|---|---|---|
| Jun 4, 2020 | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S SR MRI, Model Number W3SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S DR MRI, Model Number W3DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Patient Connector, Model Number 24967 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | CareLink SmartSync Device Manager, Model Number 24970A | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 30, 2020 | MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Apr 30, 2020 | MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx On... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Apr 30, 2020 | MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Mar 18, 2020 | H12+ and patient cable for the H12+ Holter Recorders with the following devic... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Feb 28, 2020 | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fi... | ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that t... | Class II | Argo Medical Technologies Ltd |
| Feb 27, 2020 | CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue numbe... | The wall charger may not properly charge the infusion pump battery. | Class II | CME America LLC |
| Feb 13, 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated power... | Due to programming errors in the Controller, an increase in the set motor parameters can be made ... | Class II | Sunrise Medical (US) LLC |
| Feb 4, 2020 | CareFusion Alaris Syringe Module, Model 8110 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris Pump Module, Model 8100 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris PCA Module, Model 8120 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 108854038... | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 22, 2020 | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. S... | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... | Class II | Braemar Manufacturing, LLC |
| Jan 22, 2020 | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. S... | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... | Class II | Braemar Manufacturing, LLC |
| Jan 13, 2020 | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th... | if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorde... | Class II | Philips North America, LLC |
| Dec 12, 2019 | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | Combination of software and a component failure may cause audible alarms not to operate properly,... | Class I | ResMed Ltd. |
| Dec 2, 2019 | Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with... | One brand of batteries have a small dimensional difference in the negative button terminal, which... | Class II | Polymer Technology Systems, Inc. |
| Dec 2, 2019 | PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, ... | One brand of batteries have a small dimensional difference in the negative button terminal, which... | Class II | Polymer Technology Systems, Inc. |
| Dec 2, 2019 | Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 | One brand of batteries have a small dimensional difference in the negative button terminal, which... | Class II | Polymer Technology Systems, Inc. |
| Dec 2, 2019 | PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, w... | One brand of batteries have a small dimensional difference in the negative button terminal, which... | Class II | Polymer Technology Systems, Inc. |
| Nov 4, 2019 | Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of ... | The indicator may show available charge when the battery is close to depletion. As a result, the ... | Class II | Becton Dickinson & Company |
| Oct 28, 2019 | Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightwei... | There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially ... | Class I | Smiths Medical ASD Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and I... | Class III | Theralase Inc. |
| Sep 16, 2019 | SAROS Oxygen System Model 3000 | There is an electronics control issue that causes the unit to not power on with battery power only. | Class II | Caire, Inc. |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Jun 28, 2019 | Workstation, G2, Configured (P/N 000-0241) | Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the... | Class II | Intellijoint Surgical, Inc. |
| Jun 24, 2019 | TAPSYSTEM Model 2A, REF 8002A | There is a potential for an assembly error resulting in the battery wire being connected to the O... | Class III | Cardiocommand Inc. |
| Jun 17, 2019 | Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card... | Battery short-run times and unanticipated stoppage may be due to user not performing battery main... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 7, 2019 | Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535... | The AC power module may fail at a higher than expected rate. If a fully charged battery is not p... | Class II | Philips North America, LLC |
| May 20, 2019 | Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used... | Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o... | Class II | Medtronic Inc. |
| May 10, 2019 | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode... | Possible corrosion of the battery contact(s). | Class III | Cardiocommand Inc. |
| Mar 28, 2019 | IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: ... | The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... | Class II | Philips North America, LLC |
| Mar 28, 2019 | IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: ... | The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... | Class II | Philips North America, LLC |
| Mar 28, 2019 | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564... | The MX40 may experience increased power consumption and may have a lack of visual and/or audible ... | Class II | Philips North America, LLC |
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.