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.

41001–41025 of 50511

  • HighFDA (Devices)·Z-1870-2014·2014-07-02

    Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint

    Intuitive Surgical is recalling 20 units of the IS4000 da Vinci Xi 30 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.

    Product
    IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1831-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1844-2014·2014-07-02

    Puritan Bennett 840 Ventilator Recall for Display Loss

    Nellcor Puritan Bennett is recalling 104 Puritan Bennett 840 Ventilators due to reports of loss of graphical user interface display information while the device continues to provide breath support.

    Product
    Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2014·2014-07-02

    Stryker Shaver Handpiece Sterilization Tray Recalled for Validation Deficiencies

    Stryker Endoscopy is recalling 1,992 Shaver Handpiece Sterilization Trays because the provided STERRAD 100S sterilization parameters did not fully consider all worst-case scenarios during validation testing.

    Product
    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1841-2014·2014-07-02

    SeaSpine Recalls UCR 3mm Hex Large Axial Driver Due to Tip Deformation

    SeaSpine Inc is recalling seven units of the UCR 3mm Hex, Large Axial Driver because the tip may twist or become rounded during use.

    Product
    Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1853-2014·2014-07-02

    Nidek RT-5100 and RT-3100 Refractors Recalled for Potential Injury

    Nidek Inc is recalling RT-5100 and RT-3100 refractors because the near point chart arm may lower spontaneously, posing a risk of patient injury.

    Product
    RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1848-2014·2014-07-02

    SteriGear Recalls Urinary Drain Bags Due to Valve Malfunction

    SteriGear is recalling 110,560 urinary drain bags because the valve can close and create negative pressure, potentially blocking urine flow.

    Product
    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH 600 and DxH 800 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 600 and DxH 800 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1849-2014·2014-07-02

    Western VIPR Pressure Regulators Recalled for Cylinder Separation Risk

    Western / Scott Fetzer Company is recalling Model RG3000 and RG4000 Series Valve Integrated Pressure Regulators (VIPR) because they may separate from aluminum cylinders.

    Product
    Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2014·2014-07-02

    JAS Diagnostics Recalls Glucose Hexokinase Reagent Lots for Performance Issues

    JAS Diagnostics Inc. is recalling specific lots of Glucose Hexokinase Liquid Reagent because they do not perform according to specifications.

    Product
    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1828-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·14V386000·2014-07-01

    Mercedes-Benz Recalls 2014 SL and SLK Models for Air Bag Defect

    Mercedes-Benz is recalling 2014 SL and SLK models because the front passenger air bag may not deploy properly, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SL550, SLK55, SL63, SLK250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V395000·2014-07-01

    Land Rover Recalls LR2 and Range Rover Evoque for Air Bag Defect

    Land Rover is recalling 2010-2015 LR2 and 2012-2013 Range Rover Evoque vehicles because a component failure may disable the front passenger air bag, increasing injury risk in a crash.

    Product
    LAND ROVER — LAND ROVER LR2, RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14C004000·2014-06-30

    Graco Recalls Rear-Facing Child Restraints Due to Stuck Harness Buckle

    Graco is recalling specific rear-facing child seats because the harness buckle may get stuck, making it difficult to remove a child in an emergency.

    Product
    CHILD SEAT:HARNESS/CROTCH BUCKLE recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V380000·2014-06-30

    Nova Bus Recalls LFS Transit Buses Due to ABS Warning Light Defect

    Nova Bus is recalling 796 LFS transit buses from model years 2004 and 2006-2013 because the ABS malfunction light may not illuminate if the control unit loses power.

    Product
    NOVA BUS — NOVA BUS LFS, NOVA LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V378000·2014-06-27

    Jomac Recalls 2009-2013 Ford Super Duty Vehicles Due to Fire Risk

    Jomac is recalling 2009-2013 Ford F-350, F-450, and F-550 vehicles modified with specific PTO assemblies because oil leaks may cause a fire.

    Product
    JOMAC — JOMAC FORD F-550, FORD F-350, FORD F-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V375000·2014-06-27

    GM Recalls 2013-2014 Chevrolet Caprice and SS for Wiper Defect

    General Motors is recalling 2013-2014 Chevrolet Caprice and 2014 Chevrolet SS vehicles because windshield wiper motor gears may strip, causing wipers to stop working and reducing visibility.

    Product
    CHEVROLET — CHEVROLET CAPRICE, CHEVEROLET SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14738·2014-06-26

    Roland Recalls RD-800 Digital Pianos Due to Electrical Shock Hazard

    Roland is recalling approximately 640 RD-800 digital pianos because the AC power cord can be connected to XLR output jacks, posing an electrical shock hazard.

    Product
    Digital Electric Piano
    Category
    Consumer Product
    Distribution
    Distributed nationwide