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.

Clear
DateProductReasonClassFirm
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.