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.

35676–35700 of 50504

  • HighFDA (Devices)·Z-1735-2016·2016-06-01

    American Surgical Recalls Americot Blue Sponges Due to Packaging Defects

    American Surgical Company is recalling 37 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1395-2016·2016-06-01

    Kool-Aid Jammers Cherry Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Cherry due to the possible presence of glass fragments.

    Product
    Kool-Aid Jammers Cherry packaged in a red box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1758-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defects

    American Surgical Company is recalling specific lots of strung cotton balls because defective packaging may compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect

    American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 155 boxes distributed worldwide.

    Product
    American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The recall covers 178 boxes distributed worldwide.

    Product
    American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1396-2016·2016-06-01

    Kool-Aid Jammers Tropical Punch Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Tropical Punch due to the possible presence of glass fragments.

    Product
    Kool-Aid Jammers Tropical Punch packaged in a red blue and purple box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1754-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Sterility Compromise

    American Surgical Company is recalling 13 boxes of strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 4 cases distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1383-2016·2016-06-01

    Mighty Leaf Organic Ginger Peach Iced Tea Recalled for Salmonella Risk

    Mighty Leaf Tea is recalling Organic Ginger Peach Iced Tea due to potential Salmonella contamination identified by a supplier.

    Product
    Mighty Leaf Tea Company Organic Ginger Peach Iced Tea; 100/1 oz. per case Item number 60001. UPC: 00656252600019
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-1743-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling 32 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V393000·2016-06-01

    Volvo Recalls 2017 VNL Trucks Due to Engine Stall Risk

    Volvo Trucks North America is recalling 136 model year 2017 VNL trucks because an engine control module defect may cause an unexpected engine stall, increasing crash risk.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2016·2016-06-01

    Limacorporate SMR Glenosphere Impactor/Extractor Recalled for Intra-operative Breakage

    Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.

    Product
    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 113 boxes of Delicot 6 mm x 50 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defect

    American Surgical Company is recalling 35 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling 39 boxes of Uniqcot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers three boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 38 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The affected lot is distributed worldwide.

    Product
    American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 70 units of strung cotton balls because defective packaging may compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 15 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1394-2016·2016-06-01

    Kool-Aid Jammers Grape Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Grape due to the possible presence of glass fragments. Consumers should stop using the product.

    Product
    Kool-Aid Jammers Grape packaged in a purple and red box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1802-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling Telfa neurosurgical and nonneurosurgical sponges because defective packaging may compromise sterility.

    Product
    American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall affects 266 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide