The Recall Desk

Hazard

Device Malfunction recalls

877 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device malfunction recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

176–200 of 877

  • HighFDA (Devices)·Z-2338-2025·2025-08-27

    ESG-410 Electrosurgical Generator Recalled for System Error and Reboot Malfunction

    The Olympus ESG-410 Electrosurgical Generator may display an E0662 system error and reboot unexpectedly. The FDA Class II recall affects 155 units distributed nationwide, with specific serial numbers listed in the recall notice.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2025·2025-08-27

    Electrosurgical Generator ESG-410 Recalled for System Error and Reboot Malfunctions

    Olympus ESG-410 Electrosurgical Generators may display a system error and reboot or enter continuous reboot loops during use. This could interrupt surgical procedures.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2181-2025·2025-08-20

    Ambu SPUR II Resuscitators Recalled for Blocked Manometer Port

    Ambu Inc. is recalling 87,156 SPUR II Resuscitator units because the manometer port may become blocked, rendering the manometer non-functional. The recall affects models distributed nationwide and in Canada.

    Product
    Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2025·2025-08-20

    Sparrow Ascent Patient Controller Recalled for Cable Disconnect

    Spark Biomedical is recalling the Sparrow Ascent Patient Controller neurostimulator due to a manufacturing defect that causes cable disconnect errors and interrupts stimulation output. The recall affects 78 units distributed nationwide.

    Product
    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2025·2025-08-13

    Immunoassay Analyzer Motor Current Setting Error Causes Motion Delays

    Beckman Coulter's DxI 800 immunoassay analyzers with certain software versions have a motor current setting that incorrectly resets during updates, potentially delaying patient test result reporting.

    Product
    DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2025·2025-08-13

    Stryker SmartPump Tourniquet cuff flange may detach during surgery

    Stryker SmartPump Tourniquet cuff flanges may detach during use, causing potential hemorrhage and cardiovascular collapse. Distributed nationwide and internationally.

    Product
    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2025·2025-08-06

    Automated External Defibrillators recalled due to shock delivery malfunction

    HeartSine SAM 350P, 360P, and 450P automated external defibrillators may fail to deliver electrical shocks due to a component manufacturing defect. Approximately 190,516 units are affected worldwide.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2025·2025-08-06

    IontoPatch 80 Iontophoresis Patch Therapy Pads Fail to Absorb Saline Solution

    LTS Therapy Systems is recalling the IontoPatch 80 iontophoresis patch because the nonwoven pads do not absorb the saline solution required for proper device operation. Approximately 63,936 units were distributed nationwide.

    Product
    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2025·2025-08-06

    Iontophoresis Patch Therapy Device Recalled for Non-Absorbing Pads

    LTS Therapy Systems is recalling IontoPatch STAT transdermal patches because the nonwoven pads fail to absorb saline solution, preventing the device from functioning as intended.

    Product
    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor Drill units recalled due to reverse battery orientation

    Phasor Drill neurosurgical units with reversed battery orientation are being recalled. The recall affects 1,064 units distributed across the United States and U.S. territories.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow Disposable Suction/Irrigator Malfunction Recall

    Stryker is recalling StrykeFlow disposable suction/irrigators because irrigation solution may leak into the handpiece and battery pack, causing potential device malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2025·2025-07-30

    Stryker StrykeFlow Suction Irrigator Recalled for Potential Liquid Leakage

    Stryker is recalling its StrykeFlow suction/irrigator device due to potential irrigation solution leakage into the handpiece and battery pack, which could cause device malfunction.

    Product
    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2025·2025-07-23

    FDA Recalls NIO Intraosseous Device for Stabilizer Release Failure

    Waismed Ltd. is recalling the NIO Intraosseous Device Adult due to a manufacturing defect where the built-in stabilizer may not release properly after deployment, potentially affecting emergency medical access procedures.

    Product
    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2025·2025-07-23

    NIO Intraosseous Device Adult recalled due to stabilizer release failure

    The NIO Intraosseous Device Adult manufactured by Waismed Ltd. may not properly release its built-in stabilizer after insertion due to a manufacturing error, potentially complicating emergency intraosseous access procedures.

    Product
    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2025·2025-07-09

    Philips Ultrasound Transducers Recalled: Refurbished Beyond Useful Life

    Philips is recalling 5,230 ultrasound transducers that were refurbished beyond their useful life. Devices may not perform as designed and should not be used.

    Product
    Philips L12-3 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2025·2025-07-09

    Philips V6-2 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life

    Philips Ultrasound recalls approximately 5,230 V6-2 ultrasound transducers that were refurbished beyond their useful life. The devices are distributed nationwide and internationally across more than 50 countries.

    Product
    Philips V6-2 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2025·2025-07-09

    Philips X6-1 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life

    Philips Ultrasound is recalling 5,230 X6-1 transducer units that were refurbished beyond their useful life. These devices may not perform reliably due to refurbishment beyond manufacturer specifications.

    Product
    Philips X6-1 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2025·2025-07-09

    IV Catheters in Medline Kits May Fail to Retract During Insertion

    Medline is recalling IV catheters in convenience kits because the needle may be slow to retract or fail to retract during insertion. 186 units were distributed nationwide in six states.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2025·2025-07-09

    Philips X8-2t Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound is recalling approximately 5,230 X8-2t ultrasound transducers that were refurbished beyond their useful life. The devices were distributed nationwide and internationally.

    Product
    Philips X8-2t Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2025·2025-07-09

    Philips 3D9-3v Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life

    Philips recalls 3D9-3v ultrasound transducers that were refurbished beyond their useful life, risking unreliable device performance. About 5,230 units were distributed nationwide and to 50+ countries.

    Product
    Philips 3D9-3v Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide