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.

30251–30275 of 50499

  • HighFDA (Food)·F-0494-2018·2017-12-20

    JLM Manufacturing Recalls Dark Chocolate Coffee Beans for Undeclared Milk

    JLM Manufacturing LLC is recalling dark chocolate coffee beans due to undeclared milk and butterfat. The products were distributed to multiple states.

    Product
    Dark Chocolate Coffee Beans, Natural Dark Chocolate Coffee Beans
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-0227-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0482-2018·2017-12-20

    Wegmans Dark Chocolate Strawberries Recalled for Undeclared Milk

    First Source, LLC is recalling Wegmans Dark Chocolate Strawberries because the product contains undeclared milk, a major food allergen.

    Product
    Wegmans Dark Chocolate Strawberries 13.5oz (383g) tub, UPC: 0 77890 38187 8
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0495-2018·2017-12-20

    JLM Manufacturing Recalls Dark Chocolate Raisins for Undeclared Milk

    JLM Manufacturing LLC is recalling Dark Chocolate Raisins due to undeclared milk and butterfat. The products were distributed to multiple states.

    Product
    Dark Chocolate Raisins, Natural Dark Chocolate Raisins
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-0484-2018·2017-12-20

    Favourites Dark Chocolate Covered Almonds Recalled for Undeclared Milk

    First Source, LLC is recalling Favourites Dark Chocolate Covered Almonds because they contain undeclared milk. The products were distributed in 23 US states and Canada.

    Product
    (Canada) - Favourites Dark Chocolate Covered Almonds 113 grams UPC: 0 23637 42849 8 & 92grams UPC: 0 2367 42864
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0224-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0480-2018·2017-12-20

    First Source Recalls Chocolate Almonds for Undeclared Milk

    First Source, LLC is recalling Wegmans and 7 Select dark chocolate almond products because they contain undeclared milk.

    Product
    (1)Wegmans Dark Chocolate Almonds with Sea Salt and Turbinado Sugar 12oz. tub (340g) UPC: 0 77890 37539 6 (2) 7 Select Dark Chocolate Turbinado Almonds with Sea Salt 2.25 OZ (63g) bag UPC: 0 52548 59131 1
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0239-2018·2017-12-20

    FDA Recalls Piranha Cervical Spine Screws Due to Incorrect Length Marking

    The FDA is recalling 82 Piranha screws used in cervical spine surgery because some units marked as 12 mm actually measure 14 mm.

    Product
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0230-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Slender Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2018·2017-12-20

    Elekta ERGO++ Medical Device Recall for Incorrect DICOM Mapping

    Elekta Inc is recalling 182 ERGO++ devices due to incorrect DICOM mapping of collimator or couch angles, which may lead to incorrect rotation during planning.

    Product
    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the introducer handles may detach from the sheath during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2018·2017-12-20

    Fujifilm FDR Visionary Suite X-ray Tube Recall for Cracking Risk

    Fujifilm is recalling three FDR Visionary Suite systems because cracks may develop in the X-ray tube holding shaft, posing a potential safety issue.

    Product
    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0485-2018·2017-12-20

    First Source Recalls Dark Chocolate Almonds for Undeclared Milk

    First Source, LLC is recalling Circle K Favourites Dark Chocolate Covered Almonds because they contain undeclared milk. The product was distributed in 23 U.S. states and Canada.

    Product
    (Canada) Circle K Favourites Dark Chocolate Covered Almonds 113grams UPC: 0 2367 42849
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0455-2018·2017-12-20

    Kellbran Drizzled Vanilla Popcorn Recalled for Undeclared Soy Allergen

    Kellbran Candies and Snacks Inc is recalling 520 bags of Drizzled Vanilla Popcorn because soy was not declared in the ingredient statement.

    Product
    DRIZZLED VANILLA POPCORN Net Wt. 3 oz (84.9g) Ingredients: Popcorn, corn syrup, sugar, lecithin***ALLERGY INFO: Manufactured in a facility that processes Milk, Wheat, Soy, Tree Nuts, Peanuts Stew Leonard's 100 Westport Ave., Norwalk, CT
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0226-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V837000·2017-12-20

    Nissan Recalls 2018 Versa Note Vehicles for Side Air Bag Defect

    Nissan is recalling 2018 Versa Note vehicles because a side curtain air bag component may detach during deployment, posing a projectile hazard.

    Product
    NISSAN — NISSAN VERSA NOTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0443-2018·2017-12-20

    Colorado Nut Co Recalls Honey Nutty Granola for Undeclared Milk

    Colorado Nut Co is recalling Honey Nutty Granola because it contains undeclared milk. Consumers with the product should stop eating it.

    Product
    Honey Nutty Granola (8 oz. bag), UPC 018142352147. Packaged in Plastic Zip Lock bags. No refrigeration needed.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0483-2018·2017-12-20

    Tops Dark Chocolate Coffee Beans Recalled for Undeclared Milk

    First Source, LLC is recalling Tops Dark Chocolate Coffee Beans because they contain undeclared milk, a major allergen.

    Product
    Tops Dark Chocolate Coffee Beans Net Wt 12 OZ (340g) UPC: 0 70784 51027 9
    Category
    Food
    Distribution
    23 states