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.

24226–24250 of 50442

  • HighFDA (Food)·F-0334-2020·2019-12-18

    CornFusion Caramel Popcorn Recalled for Undeclared Milk Allergen

    CornFusion Gourmet Popcorn is recalling 12 packages of 7-oz caramel popcorn in Washington because the label declares butter but omits milk.

    Product
    Caramel flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0611-2020·2019-12-18

    Encore Medical Recalls EMPOWR Locking Femoral Impactor Due to Tip Breakage

    Encore Medical is recalling 410 EMPOWR Locking Femoral Impactors because the tips may break off during surgery. This defect can cause off-axis loading, device failure, and potential long-term complications.

    Product
    EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0662-2020·2019-12-18

    Paragon 28 Recalls Mislabelled Titan 3-D Wedge Implants

    Paragon 28, Inc. is recalling 64 Titan 3-D Wedge implant kits because they are permanently mislabeled with the wrong size, which could cause surgical delays.

    Product
    P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0623-2020·2019-12-18

    Integra LifeSciences Recalls CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0668-2020·2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 179 Habib EUS RFA electrode tips because capacitive coupling may cause unintended thermal injury to tissue outside the treatment area.

    Product
    Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2020·2019-12-18

    Abbott Medical Recalls Radiofrequency Grounding Pads Due to Liner Orientation Error

    Abbott Medical is recalling 8,940 radiofrequency grounding pads nationwide because an incorrectly oriented release liner may leave film on the pad, interfering with skin contact and causing uneven heating.

    Product
    Radiofrequency Grounding Pad, REF RF-DGP-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2020·2019-12-18

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco Radiation Treatment Planning System software due to incorrect energy usage during dose calculation.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0332-2020·2019-12-18

    CornFusion Maple Bacon Popcorn Recalled for Undeclared Milk Allergen

    CornFusion Gourmet Popcorn is recalling 11 packages of Maple Bacon flavored popcorn because the label declares butter but fails to declare milk.

    Product
    Maple Bacon flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0328-2020·2019-12-18

    Breakstones Cottage Cheese Recalled for Potential Plastic and Metal Contamination

    Kraft Heinz is recalling Breakstones Lowfat Large Curd Cottage Cheese due to the potential presence of red plastic and metal pieces introduced during production.

    Product
    Breakstones 2% Milkfat Lowfat Large Curd Cottage Cheese, in 16 oz. Plastic Tub, with UPC 0 21000 30053 2, 12 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2020·2019-12-18

    CP Medical Recalls Coated PGA Sutures for Tensile Strength Failure

    CP Medical Inc is recalling 2,124 coated PGA sutures because they failed to meet USP minimum average value for knot pull strength.

    Product
    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0232-2020·2019-12-18

    AC Culinary Group Recalls Chef Pineiro's Sofrito con Cilantro Due to Metal Filament

    AC Culinary Group LLC is recalling Chef Pineiro's Sofrito con Cilantro in 12 oz and 32 oz sizes due to a customer complaint about a metal filament.

    Product
    Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0678-2020·2019-12-18

    Maquet ROTAFLOW Drive Recalled for Loose Cable Connection

    Maquet is recalling 11 ROTAFLOW Drive units because a loose cable connection may cause fluctuating flow values on the console.

    Product
    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0656-2020·2019-12-18

    Ligamax 5 mm Endoscopic Clip Applier Recalled for Sterility Breach Risk

    Ethicon Endo-Surgery Inc is recalling Ligamax 5 mm Endoscopic Multiple Clip Appliers due to potential holes in the Tyvek lidding that could breach sterility.

    Product
    Ligamax 5 mm Endoscopic Multiple Clip Applier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0327-2020·2019-12-18

    House Foods Chinese Mabo Tofu Sauce Recalled for Weak Seals

    House Foods America Corporation is recalling Chinese Mabo Tofu Sauce due to weak pouch seals that may leak and allow microorganism growth.

    Product
    House Foods Chinese Mabo Tofu Sauce, mild; NET WT. 5.29 oz. (150 g) 4 servings UPC: 0 77377 74064 8 Ingredients: Water, Tomato Paste, Soybean paste (soybean, rice, salt, water), monosodium glutamate, garlic, sugar, sesame oil, ginger, spring onion, salt, cornstarch. mirn…
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0222-2020·2019-12-18

    Skidmore Sales Recalls CBI BG 2280/45025 for Undeclared Soy Lecithin

    Skidmore Sales & Distributing Co Inc is recalling CBI BG 2280/45025 because the product contains undeclared soy lecithin.

    Product
    CBI BG 2280/45025, 50 lb. package, 1 poly bag in cardboard box, 1140496
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0333-2020·2019-12-18

    CornFusion Caramel Apple Popcorn Recalled for Undeclared Milk Allergen

    CornFusion Gourmet Popcorn is recalling Caramel Apple flavored popcorn because the label declares butter but fails to declare milk, a major allergen.

    Product
    Caramel Apple flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0336-2020·2019-12-18

    Jolly Rancher Hard Candies Recalled for Undeclared Soy Lecithin

    Werner Gourmet Meat Snacks is recalling Jolly Rancher hard candies due to undeclared soy lecithin. The product was distributed nationwide and in Canada.

    Product
    Jolly Rancher product is hard candies, individually wrapped in flexible plastic wrap, and package in plastic bag. Net weight 2 oz or 4.5 oz. UPC on the 4.5 oz. bag: 7 09972 80101 0. The label of the retail bag is read in parts: INGREDIENTS: CORN SYRUP, SUGAR, CONTAINS 2%…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0329-2020·2019-12-18

    Breakstones Cottage Cheese Recalled for Potential Plastic and Metal Contamination

    Kraft Heinz is recalling Breakstones 4% Milkfat Large Curd Cottage Cheese due to the potential presence of red plastic and metal pieces introduced during production.

    Product
    Breakstones 4% Milkfat Large Curd Cottage Cheese, in 24 oz. Plastic Tub, with UPC 0 21000 12285 1, 12 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V905000·2019-12-18

    Cruise Car Moke Recalled for Incorrect Windshield Glass Quality Rating

    Cruise Car is recalling 2019 Moke vehicles because they may have windshields with incorrect glass quality ratings, which could affect driver visibility and increase crash risk.

    Product
    CRUISE CAR — CRUISE CAR MOKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V903000·2019-12-18

    Ford Recalls 2020 F-150 Trucks Due to Damaged Spare Tires

    Ford is recalling 2020 F-150 trucks because the 17-inch spare tire may be damaged, increasing crash risk. Dealers will replace the tire free of charge.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide