The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

101–125 of 52881

  • HighFDA (Devices)·Z-2990-2026·2026-08-26

    Medicom Recalls Neurological Sponges Due to Endotoxin Variability

    Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

    Product
    American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2989-2026·2026-08-26

    Medicom Recalls Neurological Sponges Due to Endotoxin Variability

    Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

    Product
    American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2980-2026·2026-08-26

    Medtronic MiniMed 640G Insulin Pumps Recalled for Chemical Damage Risk

    Medtronic is recalling 16 MiniMed 640G insulin pumps distributed in Europe because chemical cleaning may have damaged the devices, risking incorrect insulin delivery.

    Product
    MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2977-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems due to a potential for arterial sheath tip separation or partial tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2958-2026·2026-08-26

    Arrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns

    Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.

    Product
    Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2026·2026-08-26

    restor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect

    restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.

    Product
    Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2982-2026·2026-08-26

    Medtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk

    Medtronic is recalling 257 MiniMed 780G insulin pumps distributed in Europe because chemical cleaning agents may have damaged the devices, risking incorrect insulin delivery.

    Product
    MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2963-2026·2026-08-26

    Maquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission

    Maquet Critical Care AB is recalling nine Y Sensor Modules for the SERVO-U/-N ventilator systems because they did not undergo required electrical safety and functional tests during production.

    Product
    GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2970-2026·2026-08-26

    Gentherm Medical Recalls Blanketrol III Thermal Regulating Systems

    Gentherm Medical is recalling 9,714 Blanketrol III thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.

    Product
    Blanketrol III, Model 233; Thermal regulating system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V549000·2026-08-25

    Mitsubishi Recalls Outlander Models for Rearview Camera Software Defect

    Mitsubishi is recalling 2025-2026 Outlander and 2026 Outlander PHEV vehicles because a software error may prevent the rearview camera image from displaying, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER PHEV, OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V541000·2026-08-21

    Altec Recalls Aerial Devices and Digger Derricks Due to Braking Calibration Issue

    Altec is recalling specific aerial devices and digger derricks because the automatic braking system was not recalibrated after moving the front radar box, increasing crash risk.

    Product
    ALTEC — ALTEC AA SERIES AERIAL DEVICE, AM SERIES AERIAL DEVICE, DIGGER DERRICK, AN SERIES AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·26714·2026-08-20

    Koorlian Mattresses Recalled for Fire Hazard Violating Flammability Standards

    CPSC recalls Koorlian mattresses sold on Amazon due to fire risks from violating mandatory flammability standards. Consumers should stop using them and contact the manufacturer for a free cover.

    Product
    Koorlian Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·26C006000·2026-08-20

    Britax Recalls Infant Car Seats Due to Handle Detachment Risk

    Britax is recalling specific infant car seats because a screw in the carrying handle may come loose, causing the handle to partially detach and increasing the risk of a child falling.

    Product
    CHILD SEAT:HANDLE (INFANT) recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·26V568000·2026-08-20

    Ford F-650 SD Recall: Liftgate Platform Deck Pins May Break

    Marathon Industries is recalling one 2025 Ford F-650 SD because deck pins may break, causing the liftgate platform to fall and increasing injury risk.

    Product
    FORD — FORD F-650 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·26716·2026-08-20

    CCM Hockey Recalls FMHVR Visors and ACCHVR Accessories Due to Laceration Risk

    CCM Hockey is recalling FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories because they can crack upon impact, posing a risk of laceration or impact injury.

    Product
    FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2925-2026·2026-08-19

    Medline Bleach Wipes Recalled for Reduced Disinfection Effectiveness

    Medline is recalling bleach wipes that may lose potency before expiration, potentially allowing pathogens to survive.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2924-2026·2026-08-19

    Medline Bleach Wipes Recalled for Reduced Disinfection Effectiveness

    Medline is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness, potentially allowing pathogenic microorganisms to survive.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2928-2026·2026-08-19

    Philips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue

    Philips is recalling 4,252 Allura Xper FD interventional fluoroscopic x-ray systems worldwide due to a firmware issue that may cause loss of geometry movements.

    Product
    Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V537000·2026-08-19

    E-One Recalls Fire Trucks Due to Hydraulic Valve Defect

    E-One is recalling specific 2025-2026 fire trucks because a hydraulic valve defect may prevent outriggers from extending or retracting, potentially delaying emergency response.

    Product
    E-ONE — E-ONE CYCLONE N, CYCLONE II, TYPHOON N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2943-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

    Product
    Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2926-2026·2026-08-19

    Medline Micro-Kill Bleach Germicidal Wipes Recalled for Reduced Concentration

    Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because bleach concentration may drop below specification, potentially compromising disinfection effectiveness.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
    Category
    Medical Device
    Distribution
    Distributed nationwide