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 |
|---|---|---|---|---|
| Mar 6, 2015 | Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Compu... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accesso... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Comp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed T... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 2, 2015 | Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corp... | The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs hav... | Class II | Invacare Corporation |
| Jan 9, 2015 | The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable de... | Current labeling indicates that cycling improves device longevity in every programming scenario. ... | Class II | Medtronic Neuromodulation |
| Jan 7, 2015 | System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a ... | Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a h... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 20, 2014 | Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upg... | VCG battery ignited in a VCG unit when recharging. | Class II | Philips Medical Systems, Inc. |
| Nov 19, 2014 | Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A | 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitor... | Class II | Philips Medical Systems, Inc. |
| Oct 29, 2014 | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V... | If the power supply fan mounting screws are installed incorrectly, the ends of the screws may tou... | Class II | Respironics California Inc |
| Oct 17, 2014 | Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid... | Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Oct 7, 2014 | Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: Th... | Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Sur... | Class II | Mortara Instrument, Inc |
| Oct 6, 2014 | UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric hand... | Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece ... | Class II | Zimmer Surgical Inc |
| Sep 29, 2014 | Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system ... | It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update... | Class II | Merge Healthcare, Inc. |
| Sep 25, 2014 | ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo ... | The insulin pump may lose time and date settings during a power interruption (such as a battery c... | Class II | Roche Diagnostics Operations, Inc. |
| Sep 17, 2014 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... | Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... | Class II | Boston Scientific CRM Corp |
| Sep 17, 2014 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... | Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... | Class II | Boston Scientific CRM Corp |
| Sep 17, 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene... | A failure of a specific component may prevent the ventilators from operating on AC power or trans... | Class I | Respironics California Inc |
| Aug 5, 2014 | CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL... | The firm became aware of a potential problem that was initiated by a customer complaint. After c... | Class II | Curbell Medical, Inc. |
| Jul 28, 2014 | Minstrel (with scale) Product Usage: is a mobile passive hoist. It is inte... | ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. The... | Class II | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Jul 25, 2014 | Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (... | Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its ca... | Class II | Estill Medical Technologies, Inc |
| Jul 14, 2014 | Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S... | Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent... | Class II | Medtronic Neuromodulation |
| Jun 12, 2014 | Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350... | A small number of sealed foil pouches containing the electrodes were found to be difficult to ope... | Class II | Heartsine Technologies, Limited |
| Jun 11, 2014 | Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED... | LED battery chargers may prematurely fail and will not charge the LED battery as intended | Class II | Integra LifeSciences Corp. |
| May 9, 2014 | LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP100... | Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK... | Class II | Physio-Control, Inc. |
| Apr 29, 2014 | Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infan... | The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring... | Class II | Childrens Medical Ventures |
| Apr 24, 2014 | Baxter Amia Automated PD systems are used in the treatment of adult renal fai... | System error 01779 is produced when the battery cannot be charged due to specific voltage differe... | Class II | Baxter Healthcare Corp. |
| Apr 16, 2014 | HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - Heart... | Patients and caregivers are instructed that if a battery does not provide two hours of support or... | Class II | HeartWare Inc |
| Apr 4, 2014 | Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitor... | The risk of battery failure increases with age, when a battery remains in use longer than 3 years... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J... | Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experienc... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | GemStar Docking Station, used with GemStar infusion pump, in combination with... | There are two situations that may occur when using the GemStar Docking Station, List Number 13075... | Class I | Hospira Inc. |
| Feb 7, 2014 | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care... | The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Crit... | Class I | Draeger Medical Systems, Inc. |
| Feb 6, 2014 | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ... | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C... | Class II | Philips Medical Systems North America Inc. |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... | Class I | Hospira Inc. |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... | Class I | Hospira Inc. |
| Jan 30, 2014 | Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws i... | The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, tap... | Class II | Synthes, Inc. |
| Jan 24, 2014 | Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... | HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... | Class II | Philips Medical 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.