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.

44351–44375 of 50511

  • HighFDA (Devices)·Z-0455-2013·2012-12-12

    Stryker Neptune 2 Rover Recall Due to Binding Casters

    Stryker is recalling 154 Neptune 2 Rover units because a castor design defect can cause binding, leading to operator strain and back pain.

    Product
    Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2013·2012-12-12

    Biomet Recalls Bio-Modular Humeral Heads Due to Missing Ion Implantation

    Biomet, Inc. is recalling four Bio-Modular Humeral Heads because they are missing the ion implantation feature, which may cause increased wear and shorter implant life.

    Product
    Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1985-2012·2012-12-12

    Tomales Bay Foods Recalls Artisan Cheese for Listeria Risk

    Tomales Bay Foods is recalling specific artisan cheese varieties due to a positive environmental test for Listeria monocytogenes.

    Product
    Tomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese, from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Ireland, Italy, Switzerland, France, Holland and Greece. Varieties include Appalachian, Coolea, Cabot clothbound Cheddar, Big Rock Blue, Goat…
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·12V582000·2012-12-12

    Can-Am Spyder Fuel Cap Recall Due to Fire Risk

    Bombardier is recalling 2008-2012 Can-Am Spyder vehicles because the fuel cap may not seal properly, creating a fire hazard.

    Product
    CAN-AM — CAN-AM SPYDER GS, SPYDER RT, SPYDER RS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2013·2012-12-12

    Siemens IRON Flex Reagent Cartridges Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling IRON Flex reagent cartridges because environmental iron contamination can cause falsely elevated test results.

    Product
    Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of…
    Category
    Medical Device
    Distribution
    46 states