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.

51–75 of 877

  • HighFDA (Devices)·Z-1659-2026·2026-04-08

    Philips Allura Xper FD10C X-ray System Foot Switch Malfunction

    Philips is recalling Allura Xper FD10C X-ray imaging systems due to a wired foot switch malfunction that may prevent or intermittently interrupt imaging. The recall affects 15 units distributed across the U.S. and internationally.

    Product
    Allura Xper FD10C; System Code: 722001;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2026·2026-04-08

    Artoura Breast Tissue Expanders recalled for defective needle tips

    Mentor Texas is recalling Artoura Breast Tissue Expanders because their infusion sets contain dull or blunt needle tips that may be difficult to advance and may break during use.

    Product
    Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2026·2026-04-08

    eTRAX Needle System Starter Kit 18G Position Identification Error

    FDA recalls eTRAX Needle System Starter Kit 18G due to an error in sensor inspection and programming. The needle tip position may be incorrectly identified on the user interface.

    Product
    eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1670-2026·2026-04-08

    Philips Allura Xper FD20/20 operating room X-ray table foot switch imaging defect

    Philips has recalled the Allura Xper FD20/20 operating room X-ray table due to wired foot switch defects that may prevent or intermittently delay X-ray imaging. Five affected units have been distributed internationally.

    Product
    Allura Xper FD20/20 OR Table; System Code: 722039;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1666-2026·2026-04-08

    ALLURA Xper FD20 Biplane OR Table wired foot switch X-ray imaging malfunction

    Philips is recalling the ALLURA Xper FD20 Biplane OR Table due to a wired foot switch malfunction that may prevent X-ray imaging from being initiated or cause it to operate intermittently.

    Product
    ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1579-2026·2026-04-01

    BioFlo DuraMax Catheter Splittable Sheath Design Defect Recall

    Merit Medical Systems is recalling the BioFlo DuraMax Catheter due to a design defect that prevents proper splitting, which may result in hemorrhage, thrombosis, and other serious complications.

    Product
    BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H96510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2026·2026-04-01

    Olympus PK Cutting Forceps recalled due to defective welds

    Olympus is recalling 444 units of the PK Cutting Forceps (Model PK-CF0533) worldwide because defective welds in supplier-provided components can cause the instrument's jaw to break during surgical use.

    Product
    Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2026·2026-03-18

    GEM Premier 5000 Lab Analyzer Cartridges May Eject During Testing

    GEM Premier 5000 lab cartridges may eject repeatedly during warm-up, requiring replacement and potentially delaying patient test results. No illnesses or injuries have been reported.

    Product
    GEM Premier 5000; Part No. 00055415005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2026·2026-03-18

    GEM Premier 5000 PAK Cartridges Recalled for Increased Ejection Failures

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to an increased incidence of cartridge ejection errors during device warm-up, which may delay lab result turnaround times.

    Product
    GEM Premier 5000 PAK, Part No. 00055360004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2026·2026-03-18

    GEM Premier 5000 Cartridges Recalled for Process Control Errors

    GEM PAK cartridges for the GEM Premier 5000 laboratory analyzer may experience increased Process Control Solution Not Detected errors during warm-up, causing cartridge ejection and operational disruption. The affected product includes 1,629 units distributed worldwide.

    Product
    GEM Premier 5000; Part No. 00055415010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2026·2026-03-18

    Lab analyzer cartridges may eject during warm-up, delaying results

    Instrumentation Laboratory is recalling GEM Premier 5000 cartridges that may eject during warm-up due to Process Control Solution Not Detected errors, potentially delaying diagnostic results. The issue affects 253 units distributed worldwide.

    Product
    GEM Premier 5000; Part No. 00055430004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1530-2026·2026-03-18

    GEM Premier 5000 PAK cartridges recalled for quality control errors

    Instrumentation Laboratory recalls 1,126 GEM Premier 5000 PAK cartridges worldwide due to Process Control Solution Not Detected (PCSND) errors during warm-up that cause cartridge ejection and test delays. No illnesses or injuries reported.

    Product
    GEM Premier 5000 PAK; Part No. 00055407510.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1528-2026·2026-03-18

    GEM Premier 5000 PAK cartridges: process control detection errors recall

    Instrumentation Laboratory is recalling 489 units of GEM Premier 5000 PAK lab cartridges that may experience increased process control solution detection errors during warm-up, potentially delaying patient test results.

    Product
    GEM Premier 5000 PAK; Part No. 00055407504.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2026·2026-03-18

    GEM Premier 5000 Cartridges May Fail Quality Control Detection

    GEM PAK cartridges for the GEM Premier 5000 analyzer may fail to detect process control solution during startup, causing cartridge rejection and potential delays in patient test results. No illnesses have been reported.

    Product
    GEM Premier 5000 PAK; Part No. 00055360010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2026·2026-03-18

    GEM Premier 5000 PAK Laboratory Cartridges Recalled for Ejection Failures

    GEM Premier 5000 PAK cartridges for laboratory testing equipment may experience increased ejection failures during warm-up, requiring frequent replacement and potentially delaying test results.

    Product
    GEM Premier 5000 PAK; Part No. 00055360011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1541-2026·2026-03-18

    GEM Premier 5000 Cartridge Malfunction May Delay Lab Results

    GEM PAK cartridges in the GEM Premier 5000 may eject repeatedly during warm-up, causing operational delays. Affected cartridges will be replaced.

    Product
    GEM Premier 5000; Part No. 00055445004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2026·2026-03-11

    Olympus ShockPulse-SE Lithotripsy System Generator Connector Malfunction Recall

    Olympus is recalling 602 ShockPulse-SE Lithotripsy Systems due to generator malfunction caused by connector damage. The generator may fail to recognize the transducer, preventing proper device operation during stone fragmentation procedures.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2026·2026-03-11

    ShockPulse-SE Lithotripsy System may fail to recognize transducer probe

    Olympus recalled ShockPulse-SE Lithotripsy Systems where the generator fails to recognize the transducer probe. The issue affects 1,082 units distributed worldwide.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2026·2026-03-11

    Olympus ShockPulse-SE Lithotripsy Generator Recalled for Transducer Recognition Failure

    Olympus is recalling the ShockPulse-SE Lithotripsy System generator because damage to the transducer plug or generator receptacle may cause the device to remain in a blinking state and fail to recognize the transducer. The 1,684 affected units were distributed worldwide.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2026·2026-03-04

    Olympus Resection Sheath ceramic tip breaking recalled nationwide

    Olympus is recalling 207 units of a resection sheath (Model A22043T) due to complaints that the ceramic tip breaks. The device is used in urologic surgical procedures.

    Product
    Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2026·2026-03-04

    Olympus Resection Sheath 8 mm Model A42011A Recalled for Ceramic Tip Breakage

    Olympus is recalling Resection Sheath Model A42011A due to complaints that the ceramic tip can break. The recall affects 899 units distributed nationwide in the United States.

    Product
    Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2026·2026-03-04

    Olympus Inner Sheath Model A2660 Recall Due to Ceramic Tip Fracture

    Olympus Corporation recalls the Inner Sheath Model A2660 used in urological endoscopic procedures due to complaints that the ceramic tip can break during use. No injuries have been reported.

    Product
    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2026·2026-02-25

    Olympus Thunderbeat surgical instrument recalled due to adverse events

    Olympus Corporation is recalling 9,542 Thunderbeat surgical instruments worldwide due to continued reports of adverse events. Users should contact the manufacturer for instructions.

    Product
    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2026·2026-02-25

    FDA Recalls Olympus Thunderbeat Surgical Device for Adverse Events

    Olympus is recalling the Thunderbeat surgical device model TB-0520IC due to continued reports of adverse events. The recall affects 140 units distributed worldwide.

    Product
    Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide