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.

30101–30125 of 50499

  • HighFDA (Devices)·Z-0335-2018·2018-01-24

    Hamilton Medical Recalls Intellicuff Standalone Devices Due to Motor Failure

    Hamilton Medical is recalling 176 Intellicuff Standalone devices because the motor may cease to function during use, potentially affecting endotracheal tube cuff pressure.

    Product
    Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0387-2018·2018-01-24

    Phadia 1000 Instrument Recalled Due to Retry Command Malfunction

    Phadia US Inc is recalling 70 Phadia 1000 Instruments nationwide because a malfunctioning Retry command may cause solution shortages and affect test results.

    Product
    Phadia 1000 Instrument, Article Number 12-3800-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2018·2018-01-24

    Medtronic KYPHON Express Directional Bone Filler Device Recall

    Medtronic is recalling KYPHON Express Directional Bone Filler Devices because the directional arrow may not align with the opening.

    Product
    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0595-2018·2018-01-24

    Ventura Foods Recalls A&W Papa Sauce Due to Plastic Foreign Object

    Ventura Foods is recalling A&W Papa Sauce because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    A&W All American Food Papa Sauce; 8/24 OZ. Pouches; Net Wt 12 LB. Paced Exclusively For Use By: A&W and its franchisees., Lexington, KY 40611; Use by: 04 29 18 and 04 30 18;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0577-2018·2018-01-24

    Reef Net Wild Pacific Smoked Salmon Recalled for Undeclared Soy

    Barlean's Fishery is recalling Reef Net brand Wild Pacific Smoked Salmon because the product contains undeclared soy lecithin, a major allergen.

    Product
    REEF NET brand Wild Pacific Smoked Salmon. Product is Ready-To-Eat, hot smoked, vacuum packaged in 1 lb.; 1.5 lbs.; and 2 lbs. package, keep refrigerated or keep frozen. The label is read in parts: "***REEF NET Brand *** Wild Pacific Smoked Salmon***Ingredients: Fish…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0374-2018·2018-01-24

    Boston Scientific Recalls Pacemakers Due to Sensor Signal Issues

    Boston Scientific is recalling PROPONENT DR Pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.

    Product
    PROPONENT DR Pacemaker
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0388-2018·2018-01-24

    Philips Brilliance iCT Recalled for Potential Fastener Torque Defect

    Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0575-2018·2018-01-24

    Crown Candy Coconut Bon Bons Recalled for Undeclared Pecan Allergen

    Crown Candy Corporation is recalling Old Fashioned Coconut Bon Bons because intermittent labeling errors caused some tubs to be mislabeled with Pecan Divinity ingredients, resulting in an undeclared pecan allergen.

    Product
    Old Fashioned Coconut Bon Bons; Net Wt. 6.5 OZ. (184g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 6.5 oz. clear plastic tubs with clear plastic lids.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·18E006000·2018-01-24

    Dainese Recalls AGV Carbon Modular Helmets Due to Chin Bar Defect

    Dainese is recalling 325 AGV Carbon Modular motorcycle helmets because glue may have caused the chin base material to deteriorate, increasing injury risk.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2018·2018-01-24

    Fujifilm Aspire HD Plus Mammography Machines Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.

    Product
    Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0587-2018·2018-01-24

    Namak Para Recalled for Undeclared Wheat and Milk Allergens

    New Punjab Sweets Inc. is voluntarily recalling Namak Para due to undeclared wheat and milk allergens. The product was distributed in Illinois and Wisconsin.

    Product
    Namak Para 1 lb. clear plastic clamshell containers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0381-2018·2018-01-24

    Owen Mumford Recalls Unifine Pentips Due to Potential Sterility Compromise

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Users should check for discoloration or yellowing of the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide