The Recall Desk

Hazard

Malfunction recalls

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

What the numbers show

Total
229
Critical
2
Severe
20
Most recent
2026-09-02

Of the 229 malfunction recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (9%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all 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.

1–25 of 229

  • HighFDA (Devices)·Z-3017-2026·2026-09-02

    Fresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects

    Fresenius Medical Care is recalling 1,140 BlueStar Hemodialysis machines due to reported flow, water, or temperature-related alarms.

    Product
    Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2761-2026·2026-07-29

    Olympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults

    Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.

    Product
    Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·26603·2026-07-02

    Roman Candles 8 Shot Fireworks Recalled for Explosion and Burn Hazards

    Winco Fireworks International is recalling Roman Candles 8 Shot 3-Pack firework devices because the fireworks can malfunction and shots can blow out the side of the tube, posing a risk of serious injury from explosion and burn hazards. No injuries have been reported.

    Product
    Roman Candles 8 Shot 3-Pack Firework Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2285-2026·2026-06-10

    Philips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue

    Philips Medical Systems is recalling 27 Philips Azurion 3M15 units because a software issue can cause unusable dark images during imaging procedures.

    Product
    Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·26494·2026-05-14

    Electric Start Pressure Washers Recalled for Carbon Monoxide Hazard

    Generac and DR Power electric start pressure washers are recalled because the electronic start/stop button can malfunction and self-start the unit, creating a risk of serious injury or death from carbon monoxide poisoning in confined spaces. No injuries have been reported.

    Product
    Electric Start Pressure Washers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1667-2025·2025-05-14

    CADD-Solis Ambulatory Infusion Pump False Alarm Malfunction

    Smiths Medical is recalling CADD-Solis and CADD-Solis VIP ambulatory infusion pumps because they may trigger a false upstream occlusion alarm that interrupts therapy, risking serious patient injury or death.

    Product
    CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2025·2025-01-29

    Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled for inverted clamps

    Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.

    Product
    Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2025·2025-01-22

    ProGrasp Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical recalls ProGrasp Forceps instruments due to increased complaints of frayed or broken grip cables. Approximately 99,249 units distributed in the U.S. and internationally are affected.

    Product
    8MM,PROGRASP FORCEPS,IS4000 REF 471093
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0776-2025·2025-01-08

    Baxter Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter Healthcare is recalling certain infusion pumps that were released after repair without complete testing. Incomplete testing could affect how the device delivers medication to patients.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0701-2025·2024-12-25

    Augustine HOT DOG Temperature Management Controller Instructions Update

    Augustine Temperature Management is issuing an instructions for use update for its HOT DOG warming controllers (Models WC77, WC77D, WC77R) regarding a power-on self-test error code.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0337-2025·2024-11-20

    IV Fluid Pouches Found to Leak During Filling

    The Metrix Company is recalling SECURE 50 mL EVA containers used for intravenous fluid administration because a limited number of pouches have been found to leak during filling. Affected products were distributed nationwide and to Canada.

    Product
    SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2025·2024-11-06

    Olympus Quest Spectrum 3 Fluorescent Imaging System Recalled for EMC Defect

    Olympus is recalling three Quest Spectrum 3 Fluorescent Imaging Systems in Ohio because they do not meet electromagnetic compatibility standards, which could cause malfunction during procedures.

    Product
    Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, a
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1984-2024·2024-06-12

    Vascular graft separation reported in ADVANTA VXT medical devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units have been affected worldwide.

    Product
    ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1786-2024·2024-05-15

    Evidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy

    Randox Laboratories is recalling 40 units of the Evidence MultiSTAT analyzer because a foam gasket defect may allow light to leak into the camera during testing, potentially affecting result accuracy and delaying reporting.

    Product
    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24158·2024-03-14

    Honeywell System Sensor L-Series Fire Alarm Sounders and Strobes Recall

    Honeywell is recalling about 29,000 System Sensor L-Series low frequency fire alarm sounders and strobes because they can malfunction and fail to alert people to a fire. No injuries have been reported, but two units showed low or no sound output during installation.

    Product
    System Sensor L-series low frequency Sounders and Strobes for residential apartments and commercial buildings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1070-2024·2024-03-06

    VOCSN Pediatric breathing package spiral wrap detachment risk during ventilation

    Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.

    Product
    VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ven
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0847-2024·2024-02-14

    Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.

    Product
    Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0150-2024·2023-11-01

    Monoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.

    Product
    Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2639-2023·2023-10-04

    3M Attest Sterilization Indicator Caps May Melt or Crack

    3M is recalling 172,464 units of Attest biological indicators used to validate steam sterilization because caps may melt, deform, or crack during sterilization at 132°C and 135°C.

    Product
    3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2023·2023-07-26

    Simplexa Direct Amplification Disc Kit recalled for potential liquid spillage

    DiaSorin Molecular is recalling the Simplexa Direct Amplification Disc Kit due to potential malfunction that could cause liquid to spill from the device.

    Product
    Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2023·2023-07-12

    TrackMaster Treadmill Recalled for Drive PCB Malfunction Risk

    Full Vision Inc. is recalling 39 TrackMaster treadmills with a drive PCB malfunction that can cause unexpected stopping, reversal, or acceleration.

    Product
    TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2023·2023-07-12

    Treadmill recalled for drive PCB malfunction causing unexpected acceleration

    Full Vision Inc recalls 95 TRACKMASTER GE T2100-ST2 treadmills with a defective drive PCB that may misread signals, causing the equipment to unexpectedly stop, reverse, or accelerate forward.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2023·2023-04-12

    Stryker Disposable Tourniquet Cuff Recalled for Pressure Regulation Failure

    Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide