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.

23376–23400 of 50435

  • HighFDA (Devices)·Z-1675-2020·2020-04-15

    AAP Implantate Soft Tissue Retractor Recalled for Manufacturing Defect

    AAP Implantate AG is recalling 7 units of soft tissue retractors because they may not be fully removed during manufacturing, potentially leaving debris in patients.

    Product
    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1643-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1689-2020·2020-04-15

    Bard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise

    Bard Peripheral Vascular Inc is recalling Jamshidi Bone Marrow Biopsy/Aspiration Needles because packaging pouches may not be sealed properly, compromising sterility.

    Product
    Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1660-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1647-2020·2020-04-15

    Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1654-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Food)·F-0882-2020·2020-04-15

    Audrey's Chia Cookies Peanut Butter Recalled for Undeclared Milk Allergen

    Health Harvest, LLC is recalling Audrey's Chia Cookies Peanut Butter because the product contains undeclared milk, a major food allergen.

    Product
    Audrey's Chia Cookies Peanut Butter, 4 OZ flexible pouch packaging, UPC Code: 858652007034, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0884-2020·2020-04-15

    Kroger Recalls Private Selection Frozen Berry Medley for Norovirus Risk

    The Kroger Co is recalling Private Selection Frozen Berry Medley due to potential norovirus contamination. Consumers should check their freezers for affected bags.

    Product
    PRIVATE SELECTION FROZEN BERRY MEDLEY in 16 oz. (10 bags per case) and 48 oz. bags (6 bags per case). UPC: 0001111079120
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-1674-2020·2020-04-15

    Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands

    Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.

    Product
    Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2020·2020-04-15

    Abbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk

    Abbott is recalling ARCHITECT C System Mixers because the blade may separate from the mixer due to screw and nut failure, leading to inadequate mixing of samples and reagents.

    Product
    ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0879-2020·2020-04-15

    Audrey's Chia Cookies Recalled for Undeclared Milk Allergen

    Health Harvest, LLC is recalling Audrey's Chia Cookies Chocolate Chip due to undeclared milk allergen. The product was distributed in Arizona and California.

    Product
    Audrey's Chia Cookies Chocolate Chip, 4 OZ flexible pouch packaging, UPC Code: 858652007003, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0878-2020·2020-04-15

    FDA Recalls Nature's Earthly Choice Organic Lentil Trio for Gluten Contamination

    Global Juices & Fruits LLC is recalling Nature's Earthly Choice Organic Lentil Trio because the product tested positive for gluten and contained barley and wheat.

    Product
    Nature's Earthly Choice Organic Lentil Trio product containing a blend of red split, black and green lentils, labeled Gluten-Free, packaged in stand up resealable pouch, 12 oz. (340 g), UPC 6 79948 10006 8. The product's label is read in parts: "*** Gluten-Free *** ORGANIC…
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·20V214000·2020-04-14

    Commercial Truck Rear Reflective Tape Obstruction Creates Visibility Risk

    Daimler Trucks is recalling certain commercial trucks where the mudflap hanger bracket partially covers rear reflective tape, reducing visibility. Owners should contact DTNA or NHTSA for free inspection and repositioning.

    Product
    FREIGHTLINER — FREIGHTLINER, STERLING, WESTERN STAR COLUMBIA, CLASSIC XL, 122SD, FLD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E021000·2020-04-10

    Winkelmann CNG Cylinder Label Recall for Inspection Compliance

    Winkelmann Flowform Technology LP is recalling 327-liter compressed natural gas cylinders because label font size and missing designations may prevent inspection, increasing fire risk.

    Product
    EQUIPMENT:OTHER:LABELS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V211000·2020-04-10

    Freightliner and Western Star trucks recalled for incorrect weight rating labels

    Daimler Trucks North America is recalling 2020-2021 Freightliner and Western Star commercial trucks with incorrect weight-rating labels. Incorrectly labeled trucks could be overloaded, increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 4900, 108SD, CORONADO, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E020000·2020-04-09

    Chrysler Recalls Mopar Rear Bed Step Kits for Ram Trucks

    Chrysler is recalling Mopar Rear Bed Step Kits for Ram heavy-duty trucks because the bed step may fail during side loading, increasing injury risk.

    Product
    STRUCTURE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V208000·2020-04-09

    Chrysler Recalls 2019-2020 Ram 1500 and Jeep Compass for Wiper Defect

    Chrysler is recalling 2019-2020 Ram 1500 and Jeep Compass vehicles because windshield wiper arms may loosen, reducing visibility and increasing crash risk.

    Product
    JEEP — JEEP, RAM COMPASS, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0874-2020·2020-04-08

    Raw Seafoods Recalls Frozen Salmon Teriyaki for Undeclared Wheat

    Raw Seafoods Inc. is recalling frozen Salmon Teriyaki products due to undeclared wheat. The recall affects specific states and products with specific best-by dates.

    Product
    Food You Feel Good About Brand, Salmon Teriyaki, Oven Safe
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1633-2020·2020-04-08

    Physio-Control Recalls LifePAK 500 AEDs Due to Contact Plating Wear

    Physio-Control is recalling 173,459 LifePAK 500 AEDs because mechanical wear on the therapy connector may prevent the device from detecting a patient, potentially delaying treatment.

    Product
    LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0877-2020·2020-04-08

    Vitamin Cottage Almond Clusters Recalled for Undeclared Peanut and Milk Allergens

    Vitamin Cottage is recalling Natural Grocers Almond Clusters in Dark Chocolate because the product contains undeclared peanut and milk allergens.

    Product
    NATURAL GROCERS ALMOND CLUSTERS DK CHOCOLATE NON-GMO, 8 oz. (227g), packed in a plastic bag, UPC 000087236088, Packaged by Vitamin Cottage Natural Food Markets, Inc., Lakewood, CO 80228
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1634-2020·2020-04-08

    Smith & Nephew Recalls NAVIO Soft Tissue Protector Due to Binding Risk

    Smith & Nephew is recalling 348 NAVIO Soft Tissue Protectors because the instrument may become stuck to bone pins during surgery.

    Product
    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected…
    Category
    Medical Device
    Distribution
    Distributed nationwide