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.

35626–35650 of 50504

  • HighFDA (Devices)·Z-1783-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling 68 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1721-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 351 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2016·2016-06-01

    Draeger D-Vapor Anesthesia Vaporizers Recalled for Anesthetic Agent Release

    Draeger Medical is recalling D-Vapor and D-Vapor 3000 anesthesia vaporizers because they may release desflurane during filling, posing an eye irritation risk.

    Product
    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2016·2016-06-01

    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 affected products were distributed worldwide.

    Product
    American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2016·2016-06-01

    American Surgical Cylindrical Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 11 boxes of cylindrical sponges because defective packaging may compromise sterility.

    Product
    American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2016·2016-06-01

    B. Braun Recalls WHIN Infusion Sets Due to Needle Protrusion Risk

    B. Braun Medical is recalling WHIN Infusion Sets because the Huber needle tip may protrude from the needle guard, posing a safety risk to patients.

    Product
    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1809-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging compromises sterility. The products were distributed worldwide.

    Product
    American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Telfa 1/2" x 1/2" sponges because defective packaging may compromise sterility. The recall covers 24 boxes distributed worldwide.

    Product
    American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 6 boxes distributed worldwide.

    Product
    American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Compromise

    American Surgical Company is recalling Delicot non-xray sponges because defective packaging compromises sterility. The recall covers 4 boxes distributed worldwide.

    Product
    American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 41 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may have compromised sterility. The recall covers 28 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Implants 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. Fastener, fixation, nondegradable, soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 3 boxes of 1-inch non-strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1770-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges because defective packaging compromises sterility.

    Product
    American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 237 units of 1-inch strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 114 cases of Ultracot sponges because defective packaging compromises sterility.

    Product
    American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2016·2016-06-01

    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.

    Product
    Various trauma and sports medicine instruments and implants. Reamer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V390000·2016-06-01

    Pierce Emergency Vehicles Recalled for Improperly Soldered Pump Strainers

    Pierce is recalling 2015-2016 emergency vehicles because pump intake strainers may be improperly soldered, risking pump damage and reduced firefighting effectiveness.

    Product
    PIERCE — PIERCE SABER, VELOCITY, IMPEL, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 21 boxes of Delicot non-xray sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 409 boxes of Delicot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2016·2016-06-01

    Biomet Recalls Trauma and Spinal Implants Due to Sterile Seal Defects

    Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.

    Product
    Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2016·2016-06-01

    American Surgical Company Recalls Neurosurgical Sponges Due to Packaging Defect

    American Surgical Company is recalling 16 boxes of Mass Eye & Ear Finger Cot Nasal sponges because defective packaging compromises sterility.

    Product
    Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 99 units of Delicot 4 mm x 50 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide