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.

35701–35725 of 50504

  • HighFDA (Devices)·Z-1786-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 315 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2016·2016-06-01

    American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot X sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.

    Product
    American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V388000·2016-06-01

    Terex Advance Recalls 2016 Concrete Mixers Due to Engine Stall Risk

    Terex Advance is recalling 2016 Front Discharge Concrete Mixers because a faulty engine control module may cause the engine to stall unexpectedly, increasing crash risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE CONCRETE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Telfa 1" x 1" neurosurgical and nonneurosurgical sponges because defective packaging compromises sterility.

    Product
    American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 15 boxes of Americot Blue sponges because defective packaging compromises sterility.

    Product
    American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V386000·2016-06-01

    Forest River Recalls Transit Buses with Defective Wheelchair Lifts

    Forest River is recalling specific transit buses equipped with Ricon wheelchair lifts due to a risk of platform separation and injury to operators.

    Product
    STARCRAFT BUS — STARCRAFT BUS, STARTRANS, GLAVAL BUS QUEST, SENATOR II, QUEST XL, TITAN II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1403-2016·2016-06-01

    Simply Delicious Recalls Lemon Poppyseed Oat Bars Due to Mispackaging

    Simply Delicious is recalling Lemon Poppyseed Oat Bars because they were mispackaged with Coconut bars. The recall covers 142 cases distributed nationwide.

    Product
    Bobo's Oat Bars, Gluten Free, Lemon Poppyseed, Net Weight 3 oz (85g), packaged in clear plastic, 12 bars per sleeve, also sold as individual units. Manufactured by Simply Delicious, Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

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

    Product
    American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 24 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1800-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defect

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

    Product
    American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2016·2016-06-01

    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. Pin, fixation, smooth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 97 boxes of Delicot 5 mm x 13 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 10 boxes of non-strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2016·2016-06-01

    Biomet Recalls Arthroscopes and Implants Due to Sterile Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and arthroscopes because insufficient seal strength on sterile packaging could allow the product to become nonsterile.

    Product
    Various trauma and sports medicine instruments and implants. Arthroscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

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

    Product
    American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1392-2016·2016-06-01

    Kraft Heinz Recalls CapriSun Tropical Punch Due to Possible Glass Fragments

    Kraft Heinz is recalling CapriSun tropical punch due to the possible presence of glass fragments. Consumers should stop using the product and contact the company for a refund.

    Product
    CapriSun tropical punch packaged in a blue and white box with pictures of fruit and white and black lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1775-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 287 boxes of Delicot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2016·2016-06-01

    American Surgical Cotton Balls Recalled Due to Packaging Sterility Defect

    American Surgical Company is recalling 7 boxes of non-strung cotton balls due to packaging defects that compromise sterility. The affected lots were distributed worldwide.

    Product
    American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defect

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall affects 262 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

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

    Product
    Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2016·2016-06-01

    American Surgical Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 54 cases distributed worldwide.

    Product
    American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide