The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

301–325 of 633

  • HighFDA (Devices)·Z-2113-2026·2026-05-13

    Medline Convenience Kits Surgical Packaging Sterilization Calibration Issue

    Medline Industries is recalling over 7,700 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0706-2026·2026-05-13

    Hatch Creamed Honey recalled for stainless steel dust and plastic particles

    Walker Honey Co is recalling Hatch Creamed Honey products that may contain stainless steel dust or small plastic particles. The affected products were packed after December 1, 2025.

    Product
    Hatch 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 UPC Code: 6
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0716-2026·2026-05-13

    Loard's Black Raspberry Ice Cream recalled for undeclared allergens

    Silver Moon LP dba Loard's Ice Cream is recalling 32 oz containers of Loard's Black Raspberry Ice Cream because the product contains undeclared milk, Red #40, and Blue #1.

    Product
    Loard's Black Raspberry Ice Cream - 32 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0737-2026·2026-05-13

    Loard's Lime Sherbert 32 oz Recalled for Undeclared Allergens

    Silver Moon LP dba Loard's Ice Cream is recalling Loard's Lime Sherbert 32 oz because the product contains undeclared milk, wheat, soy, Yellow #5, and Green #3 that are not listed on the label.

    Product
    Loard's Lime Sherbert - 32 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0730-2026·2026-05-13

    Loard's Coconut Pineapple Ice Cream recalled for undeclared milk

    Silver Moon LP dba Loard's Ice Cream is voluntarily recalling Loard's Coconut Pineapple Ice Cream in 32 oz and 56 oz sizes due to undeclared milk, a serious allergen for milk-allergic consumers.

    Product
    Loard's Coconut Pineapple Ice Cream - 32 oz; 56 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0746-2026·2026-05-13

    Loard's Pistachio Ice Cream recalled for undeclared allergens and dyes

    Loard's Pistachio Ice Cream (32 oz) is being recalled due to undeclared milk, pistachios, Yellow #5, and Blue #1. Consumers with allergies or sensitivities should not consume the product.

    Product
    Loard's Pistachio Ice Cream - 32 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0729-2026·2026-05-13

    Loard's Chocolate Ice Cream recalled for undeclared milk allergen

    Silver Moon LP dba Loard's Ice Cream is recalling Loard's Chocolate Ice Cream in 32 oz and 56 oz sizes because the product contains undeclared milk, a major allergen.

    Product
    Loard's Chocolate Ice Cream - 32 oz; 56 oz
    Category
    Food
    Distribution
    0 states
  • 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
  • HighFDA (Food)·H-0728-2026·2026-05-13

    Loard's Chocolate Showers Ice Cream recalled for undeclared milk and soy

    Silver Moon LP dba Loard's Ice Cream is recalling Loard's Chocolate Showers Ice Cream in 32 oz and 56 oz sizes due to undeclared milk and soy allergens that are not listed on the label.

    Product
    Loard's Chocolate Showers Ice Cream - 32 oz; 56 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0732-2026·2026-05-13

    Loard's Cookies and Cream Ice Cream recalled for undeclared allergens

    Loard's Cookies and Cream Ice Cream (32 oz and 56 oz sizes) is recalled because it contains undeclared milk, wheat, and soy allergens that are not listed on the label.

    Product
    Loard's Cookies and Cream Ice Cream - 32 oz; 56 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0690-2026·2026-05-13

    Montebianco Vegan Base Recalled for Undeclared Milk Allergen

    Disaronno Ingredients has recalled Montebianco Vegan Base due to undeclared milk allergen levels exceeding acceptable limits, despite a "may contain milk" label warning.

    Product
    Montebianco, 113542 Base Vegan, 2 Kg (4.41 Lb) Bag, packed 8 bags per master case of 2 Kg (4.41 lb) each total case weight,16 Kg / 35.27 lb
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0755-2026·2026-05-13

    Loard's Vanilla Ice Cream recalled for undeclared milk allergen

    Silver Moon LP dba Loard's Ice Cream is voluntarily recalling Loard's Vanilla Ice Cream (32 oz and 56 oz sizes) distributed in Northern California because the product contains undeclared milk.

    Product
    Loard's Vanilla Ice Cream - 32 oz; 56 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0738-2026·2026-05-13

    Loard's Mango Ice Cream recalled for undeclared milk and yellow dye

    Loard's Mango Ice Cream (32 oz and 56 oz) is being recalled because the product contains undeclared milk and Yellow #5. Consumers with allergies or sensitivities to milk or this food dye should not consume the product.

    Product
    Loard's Mango Ice Cream - 32 oz; 56 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0702-2026·2026-05-13

    Raspberry Creamed Honey products recalled for metal and plastic contamination

    Walker Honey Co is recalling Raspberry Creamed Honey (UPC 671333101322) distributed in Texas because the product may contain stainless steel dust/flakes or plastic particles.

    Product
    Raspberry Creamed Honey 671333101322 ¿ 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, UPC Code: 671333101322
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2104-2026·2026-05-13

    Medline PPE Kit recalled for sterilization calibration issues

    Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.

    Product
    Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2026·2026-05-13

    Medline Convenience Kits medical devices recalled due to sterilization calibration issues

    Medline is recalling Convenience Kits (Model DYNJ50806L) because equipment calibration issues may have affected the sterility assurance level of the devices. The products were exposed to sterilization and packaging cycles but the calibration problems could impact their sterility.

    Product
    Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2026·2026-05-13

    Physio-Control Defibrillators May Lack Required Performance Inspection

    Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.

    Product
    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-00193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2026·2026-05-13

    Medline Basic Nerve Block Tray sterilization calibration issue

    Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
    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-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 (Devices)·Z-2095-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries is recalling multiple convenience kits used in surgical and biopsy procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects 4,064 units distributed nationwide.

    Product
    Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2026·2026-05-13

    Medline Surgical Drapes Recalled Due to Sterilization Equipment Calibration Issues

    Medline is recalling multiple models of surgical drapes due to calibration issues with sterilization and packaging equipment that may have compromised the sterility assurance level of the products. All affected units were distributed nationwide.

    Product
    Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2026·2026-05-13

    Medline Convenience Kits Recalled Over Sterilization Calibration Issues

    Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.

    Product
    Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0736-2026·2026-05-13

    Loard's Lemon Chiffon Ice Cream recalled for undeclared allergens

    Silver Moon LP dba Loard's Ice Cream is recalling Loard's Lemon Chiffon Ice Cream (32 oz) because it contains undeclared milk, eggs, and Yellow #5, which pose a risk to consumers with allergies or sensitivities to these ingredients.

    Product
    Loard's Lemon Chiffon Ice Cream - 32 oz
    Category
    Food
    Distribution
    0 states