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.

1101–1125 of 52929

  • HighFDA (Devices)·Z-2050-2026·2026-05-13

    Prodisc C SK Cervical Implant Size Labeling Mix-Up Recall

    Centinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up: 6mm products were labeled as 5mm and 5mm products were labeled as 6mm, creating risk of implanting the wrong size.

    Product
    Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2026·2026-05-13

    BioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives

    BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.

    Product
    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0708-2026·2026-05-13

    Darkside of the Hive natural creamed honey may contain metal fragments

    Natural Creamed Honey from Darkside of the Hive is being recalled because it may contain stainless steel dust or flakes and small particles or shreds of plastic.

    Product
    Natural Creamed Honey, 671333101377 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 6
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0701-2026·2026-05-13

    Fain's blackberry honey spread may contain metal and plastic fragments

    Fain's Blackberry Honey Spread in 12 oz jars is being recalled because it may contain stainless steel dust or flakes and small particles or shreds of plastic.

    Product
    Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2125-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization equipment calibration issues

    Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.

    Product
    Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2026·2026-05-13

    Prodisc C SK cervical disc implant labeling mix-up recalled

    Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large cervical disc replacement devices due to a labeling mix-up where 6mm implants were labeled as 5mm and 5mm implants were labeled as 6mm.

    Product
    Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries is recalling two models of Convenience Kits because calibration problems with sterilization and packaging equipment may have compromised the sterility of the products.

    Product
    Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0512-2026·2026-05-13

    DELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk

    Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from perforations that may compromise sterility. The recall affects 37,215 bags distributed nationwide.

    Product
    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0718-2026·2026-05-13

    Loard's blueberry cheesecake ice cream has undeclared milk and colors

    Loard's Blueberry Cheesecake Ice Cream in 32 oz tubs is being recalled because milk, Red #40 and Blue #1 are undeclared on the label. 200 units are affected.

    Product
    Loard's Blueberry Cheesecake Ice Cream - 32 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0749-2026·2026-05-13

    Loard's raspberry sherbert has undeclared milk and Red #40

    Loard's Raspberry Sherbert in 32 oz tubs is being recalled because milk and Red #40 are undeclared on the label. 132 units are affected.

    Product
    Loard's Raspberry Sherbert - 32 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0715-2026·2026-05-13

    Loard's black raspberry marble ice cream has undeclared milk and colors

    Loard's Black Raspberry Marble Ice Cream in 32 oz tubs is being recalled because milk, Red #40 and Blue #1 are undeclared on the label. 362 units are affected.

    Product
    Loard's Black Raspberry Marble Ice Cream - 32 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2110-2026·2026-05-13

    Medline Convenience Kits for C-Section and Obstetric Procedures

    Medline Industries is recalling 12,529 units of sterile surgical convenience kits used in cesarean section and obstetric procedures worldwide due to equipment calibration issues that may compromise sterilization assurance.

    Product
    Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0710-2026·2026-05-13

    Hatch green chile creamed honey may contain metal and plastic fragments

    Hatch Green Chile Creamed Honey from Darkside of the Hive is being recalled because it may contain stainless steel dust or flakes and small particles or shreds of plastic.

    Product
    Hatch Green Chile Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0725-2026·2026-05-13

    Loard's cherry vanilla ice cream has undeclared milk and Red #40

    Loard's Cherry Vanilla Ice Cream in 32 oz tubs is being recalled because milk and Red #40 are undeclared on the label. 484 units are affected.

    Product
    Loard's Cherry Vanilla Ice Cream - 32 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0754-2026·2026-05-13

    Loard's ube ice cream has undeclared milk and four colors

    Loard's Ube Ice Cream in 32 oz tubs is being recalled because milk, Red #3, Red #40, Blue #1 and Blue #2 are undeclared on the label. 1,568 units are affected.

    Product
    Loard's Ube Ice Cream - 32 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2123-2026·2026-05-13

    Medline Triple Lumen Insertion Kits Recalled for Sterilization Calibration

    Medline Industries is recalling Triple Lumen Insertion Kits (Model DYNDM1031A) due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2026·2026-05-13

    Medline Convenience Kits sterilization and packaging calibration issues recalled

    Medline Industries is recalling multiple Convenience Kit models used in cardiac, vascular, and surgical procedures due to calibration issues with sterilization and packaging equipment that could impact sterility assurance. Approximately 39,341 units distributed worldwide may be affected.

    Product
    Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization issue

    Medline Industries is recalling 26 models of medical convenience kits used in clinical settings because equipment calibration issues may have compromised sterility assurance during sterilization and packaging.

    Product
    Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0742-2026·2026-05-13

    Loard's orange sherbert has undeclared milk and Yellow #5

    Loard's Orange Sherbert in 32 oz tubs is being recalled because milk and Yellow #5 are undeclared on the label. 150 units are affected.

    Product
    Loard's Orange Sherbert - 32 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0735-2026·2026-05-13

    Loard's horchata ice cream has undeclared milk and soy

    Loard's Horchata Ice Cream in 32 oz tubs is being recalled because milk and soy are undeclared on the label. 450 units are affected.

    Product
    Loard's Horchata Ice Cream - 32 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0776-2026·2026-05-13

    Publix bran flakes cereal recalled over plastic foreign material

    Publix Bran Flakes Wheat Cereal in 18 oz boxes is being recalled because of foreign material, specifically plastic. 13,824 units are affected.

    Product
    Publix Bran Flakes, Wheat Cereal. Net Wt 18oz (1 lb 2 oz) 510g. UPC 0 41415-24305 7. Distributed by Publix Super Markets, Inc. Lakeland, FL 33802.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0714-2026·2026-05-13

    Loard's banana ice cream has undeclared milk and Yellow #5

    Loard's Banana Ice Cream in 32 oz and 56 oz tubs is being recalled because milk and Yellow #5 are undeclared on the label.

    Product
    Loard's Banana Ice Cream - 32 oz; 56 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2102-2026·2026-05-13

    Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.

    Product
    Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide