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.

19626–19650 of 50413

  • HighFDA (Food)·F-0840-2021·2021-08-11

    Uncle Wally's Twin Muffins Chocolate Chip recalled for Listeria

    Uncle Wally's Twin Muffins - Chocolate Chip (3.75oz) are recalled nationwide because they may be contaminated with Listeria monocytogenes, a potentially dangerous bacterium.

    Product
    Uncle Wally's Twin Muffins - Chocolate Chip - 3.75oz; UPC: 759313-04104 9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2021·2021-08-11

    AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions

    The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.

    Product
    Kaguya Automated Peritoneal Dialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0832-2021·2021-08-11

    Stop n Shop Mini Corn Muffins Recalled for Listeria Contamination

    Stop n Shop 12ct Mini Corn Muffins may be contaminated with Listeria monocytogenes. Approximately 485,304 units have been distributed nationwide and should not be consumed.

    Product
    Stop n Shop 12ct Mini Corn Muffins - 12 oz.; UPC: 216053 003992
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2176-2021·2021-08-11

    Home Artificial Insemination Kit Recalled for Lack of Marketing Authorization

    Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.

    Product
    Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·21E073000·2021-08-11

    S&S Truck Parts Recalls Triangle Kits for Visibility Issues

    S&S Truck Parts is recalling Ningbo Fuding Industrial triangle kits that may be insufficiently visible, potentially increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2021·2021-08-11

    Stryker Nail Insertion Sleeve Recalled for Inner Diameter Mismatch

    Stryker GmbH is recalling 242 Nail Insertion Sleeves (Catalog Number 18061406S, Lot K03CC4F) because the inner diameter does not match the dimension specified on the outer box label.

    Product
    Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0841-2021·2021-08-11

    Uncle Wally's Twin Muffins Banana Nut Recalled for Listeria Risk

    Give and Go Prepared Foods is recalling Uncle Wally's Twin Muffins (Banana Nut, 3.75oz) due to potential Listeria monocytogenes contamination. The recall affects approximately 485,304 units distributed nationwide.

    Product
    Uncle Wally's Twin Muffins - Banana Nut - 3.75oz; UPC: 759313-89204 7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0822-2021·2021-08-11

    The Worthy Crumb Assorted Large Muffins Recalled for Listeria Risk

    GIVE AND GO PREPARED FOODS is recalling The Worthy Crumb Assorted Large Muffins nationwide due to potential Listeria monocytogenes contamination. Consumers should not eat the product.

    Product
    The Worthy Crumb Assorted Large Muffins - Blueberry Streusel / Banana Nut / Double Chocolate Chip - 3.6 oz., 16 units per tray; UPC: 7 70981-49124 0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2021·2021-08-11

    Artificial insemination kits recalled for lack of FDA authorization

    Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.

    Product
    2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0820-2021·2021-08-11

    Worthy Crumb Oreo Mini Muffins Recalled for Listeria Contamination

    Give and Go Prepared Foods is recalling The Worthy Crumb Oreo 3pack Mini Muffins due to potential contamination with Listeria monocytogenes. Affected units were distributed nationwide.

    Product
    The Worthy Crumb Oreo 3pack Mini Muffins - 2.6oz, UPC: 7 70981-16726 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0817-2021·2021-08-11

    Paximune Dietary Supplement Recalled for Potential Bacterial Contamination

    Bomunity Ltd Co is recalling Paximune Dietary Supplement (2 Fl. Oz. bottles, Lot 210402) distributed nationwide due to potential bacterial contamination.

    Product
    Paximune Dietary Supplement Contains Bovine Proteins that help Promote Health and help Modulate Immunity 2 Fl. Oz. (60ml) packaged in dark glass bottle 12 bottles per case UPC 64395 00001
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0831-2021·2021-08-11

    Great Value Banana Nut Snack Muffins Recalled for Listeria Contamination

    Great Value Banana Nut Snack Muffins distributed nationwide may be contaminated with Listeria monocytogenes. The product has been recalled, and consumers should not consume affected units.

    Product
    Great Value Banana Nut Snack Muffins - 12 oz., 8 per case; UPC: 078742-35747 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0838-2021·2021-08-11

    7-Eleven Selects Banana Nut Mini Muffins Recalled for Listeria Risk

    7-Eleven Selects Banana Nut 3-pack Mini Muffins are being recalled nationwide because they may be contaminated with Listeria monocytogenes. Consumers should not eat the affected products.

    Product
    7 Eleven Selects Banana Nut 3pack Mini Muffins - 2.6 oz. / 16 units per tray / 6 trays per case; UPC: 0 52548-67883 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0843-2021·2021-08-11

    The Worthy Crumb Banana Nut Muffins Recalled for Listeria Risk

    The Worthy Crumb Assorted Large Muffins in Banana Nut flavor (3.6oz) are being recalled nationwide because they may be contaminated with Listeria monocytogenes, a harmful bacterium that can cause serious illness.

    Product
    The Worthy Crumb Assorted Large Muffins - Banana Nut - 3.6oz; UPC: 7 70981-49137-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0823-2021·2021-08-11

    The Worthy Crumb Oreo Mini Muffins Recalled for Listeria Risk

    The Worthy Crumb Oreo 3pack Mini Muffins Tray (485,304 units) is recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard or return affected packages.

    Product
    The Worthy Crumb Oreo 3pack Mini Muffins Tray - 10 units of 2.6 oz. IW muffins, UPC: 7 70981-16731 2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0844-2021·2021-08-11

    The Worthy Crumb Double Chocolate Muffins Recalled for Listeria Contamination

    The Worthy Crumb Assorted Large Muffins in Double Chocolate flavor (3.6 oz, UPC 7 70981-49135 6) are being recalled nationwide because they may be contaminated with Listeria monocytogenes.

    Product
    The Worthy Crumb Assorted Large Muffins - Double Chocolate - 3.6oz; UPC: 7 70981-49135 6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2021·2021-08-11

    Medical Device Recall: Unauthorized Fertility Insemination Kit

    All lots of the Ultimate Fertility At Home Insemination Kit sold before December 9, 2019 are recalled. The device was distributed without FDA marketing authorization.

    Product
    Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2198-2021·2021-08-11

    Straumann SCS Screwdriver Recalled for Incorrect Tip Configuration

    Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article 046.401) due to an incorrect tip configuration that prevents proper engagement with screw heads during dental surgery, creating a potential injury risk.

    Product
    Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2021·2021-08-11

    Abbott Activated Alanine Aminotransferase Reagent May Produce Inaccurate Patient Results

    Abbott's A-ALT diagnostic reagent may produce inaccurate test results for samples with elevated enzyme or bilirubin levels, potentially affecting patient outcomes. The affected reagent kits have been distributed worldwide.

    Product
    REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2021·2021-08-11

    TenderNeeds IUI Fertility Kits Distributed Without FDA Marketing Authorization

    TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.

    Product
    TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0828-2021·2021-08-11

    Marketside Triple Chocolate Muffins Recalled for Listeria Risk

    Marketside Triple Chocolate Muffins are being recalled because they may be contaminated with Listeria monocytogenes, a harmful bacterium. Consumers who have purchased these muffins should not eat them.

    Product
    Marketside Triple Chocolate Muffins - 14 oz, 9 per case; UPC: 681131-40073 2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0821-2021·2021-08-11

    Freshness Guaranteed Party Cake Mini Muffins recalled for possible Listeria

    Freshness Guaranteed Party Cake Mini Muffins are being recalled nationwide because they may be contaminated with Listeria monocytogenes. The affected product was distributed under lot codes GBE1C, GBL1C, GCJ1C, and GCD1C.

    Product
    Freshness Guaranteed Party Cake Mini Muffins - 12 oz., 10 per case; UPC: 078742-36778 1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0819-2021·2021-08-11

    Marketside Strawberry & Creme Muffins Recalled for Possible Listeria Contamination

    GIVE AND GO PREPARED FOODS is recalling Marketside Strawberry & Creme Muffins (14oz, 8 per case) distributed nationwide due to possible contamination with Listeria monocytogenes.

    Product
    Marketside Strawberry & Creme Muffins - 14oz, 8 per case; UPC: 681131-41133 2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0830-2021·2021-08-11

    Great Value Chocolate Chip Brownie Snack Cups recalled for Listeria contamination

    GIVE AND GO PREPARED FOODS is recalling Great Value Chocolate Chip Brownie Snack Cups (12 oz., 8 per case) distributed nationwide due to potential Listeria monocytogenes contamination. Consumers should not eat the product and should return it to the place of purchase.

    Product
    Great Value Chocolate Chip Brownie Snack Cup - 12 oz., 8 per case; UPC: 078742-33099 0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2021·2021-08-11

    Fertility IUI Device Recalled for Missing FDA Marketing Authorization

    Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum due to distribution without FDA marketing authorization. All units sold worldwide prior to December 9, 2019 are affected.

    Product
    Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
    Category
    Medical Device
    Distribution
    0 states