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.

14701–14725 of 53092

  • HighCPSC·23099·2023-01-19

    NewCosplay Children's Sleepwear Recalled for Flammability Violation

    NewCosplay branded children's sleepwear fails to meet federal flammability standards, posing a burn risk. About 780 units sold on Amazon from November 2021 through May 2022 are subject to recall.

    Product
    Children's sleepwear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23094·2023-01-19

    Taylor and Finch Six-Wick Scented Candles Recalled for Fire and Injury Hazards

    Ross Stores is recalling about 5,800 Taylor and Finch six-wick scented candles because they can combust while lit, causing the glass container to break and posing fire and injury hazards. Ross has received five reports of combustion, including one report of minor injury.

    Product
    Taylor and Finch six-wick scented candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01192023-01·2023-01-19

    Hy-Vee Beef Pot Roast Entrées Recalled for Undeclared Wheat Allergen

    USDA issued a public health alert for Hy-Vee beef pot roast entrées because the gravy may contain undeclared wheat. Consumers with wheat allergies should not eat these products.

    Product
    HY-VEE FRESH COMMISSARY — FSIS Issues Public Health Alert for Ready-To-Eat Hy-Vee Beef Pot Roast Entrée Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighCPSC·23096·2023-01-19

    Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard

    Lifetime Brands has recalled about 2,700 hot chocolate pots sold at Williams-Sonoma because they are mislabeled as microwave safe. If microwaved, the metallic paint can spark and cause a fire.

    Product
    Hot Chocolate Pots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23105·2023-01-19

    Meguiar's Heavy Duty Headlight Sealant recalled for non-compliant packaging

    Meguiar's is recalling about 140,000 units of Heavy Duty Headlight Sealant because the packaging does not meet federal child-resistant requirements. Young children could be poisoned if they swallow the contents.

    Product
    Heavy Duty Headlight Sealant
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23098·2023-01-19

    Sakar International Recalls Three Helmet Models Due to Head Injury Risk

    Sakar International is recalling about 33,100 Credhedz Lizard, Crayola Dry-Erase, and Tony Hawk multi-purpose helmets because they do not meet federal safety standards for positional stability and retention, posing a risk of head injury in a crash.

    Product
    Credhedz Lizard Helmets, Crayola Dry Erase Helmets and Tony Hawk Multi-Purpose Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23093·2023-01-19

    Vanessa 42-inch Fire Tables Recalled for Fire Hazard

    Ove Decors' Vanessa 42-inch fire tables are recalled because the gas hose can melt when contacting the heat shield, causing the table to catch fire. About 470 units sold online from April 2020 through October 2022.

    Product
    Vanessa 42-inch Fire Tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V013000·2023-01-19

    2022 Chevrolet Equinox fuel pump module may cause engine stall

    General Motors is recalling certain 2021-2022 Chevrolet Equinox and 2022 GMC Terrain vehicles because the fuel pump module may not provide sufficient fuel to the engine, causing it to stall and increasing crash risk.

    Product
    GMC — GMC, CHEVROLET TERRAIN NA, EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2023·2023-01-18

    Craniotome Attachment Ball Bearings May Separate During Surgery

    The FDA is recalling a surgical craniotome attachment after ball bearings can separate from the device. Failure to follow inspection protocols may result in serious patient injury during neurosurgery.

    Product
    6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0115-2023·2023-01-18

    TriMix Injectable Medication Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection due to lack of sterility assurance. The injectable was distributed nationwide; affected patients should not use these vials and should contact their healthcare provider.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0249-2023·2023-01-18

    Sanders Assorted Milk and Dark Sea Salt Caramels recalled for brush bristle contamination

    Sanders Candy LLC is recalling Sanders Assorted Milk and Dark Sea Salt Caramels nationwide and in Canada due to cleaning brush bristles found in the product. Consumers should not eat affected candy and should return it to the retailer.

    Product
    Sanders Assorted Milk and Dark Sea Salt Caramels UPC 0-35900-31080-5 7oz Gift Box UPC 0-35900-29782-3 .5OZ Silver Box UPC 0-35900-29793-9 7OZ Silver Box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2023·2023-01-18

    McCormick Medical Distribution PORT TRAY recalled for potential sterility breaches

    Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.

    Product
    McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0227-2023·2023-01-18

    Pietrzyk Pierogi Recalled Due to Undeclared Soy Lecithin

    Pietrzyk Foods is recalling The Holy Gouda Pierogi due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.

    Product
    PIETRZYK PIEROGI THE HOLY GOUDA PIEROGI, NET WT. 26.5oz (742g), 1 DOZEN UPC 850014236069
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0118-2023·2023-01-18

    TriMix Injectable Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection (11.8mcg/18mg/0.6mg/mL) due to lack of assured sterility. Patients using affected vials should contact their healthcare provider immediately.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2023·2023-01-18

    Prostaglandin E1 Injection Recall Due to Sterility Assurance Failure

    Northern VA Compounders has recalled Prostaglandin E1 Injection Solution due to lack of assurance of sterility in the compounding process. The affected lot was distributed nationwide.

    Product
    Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2023·2023-01-18

    Medtronic Vanta LT Neurostimulation Programmer Software Anomalies Recall

    Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0122-2023·2023-01-18

    BiMix Injection Recalled for Lack of Assurance of Sterility

    Northern VA Compounders has recalled BiMix Injection due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2023·2023-01-18

    Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging

    International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.

    Product
    Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2023·2023-01-18

    Compounded Injectable Drug Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling 1,200 vials of BiMix STD 001 injectable nationwide due to lack of assurance of sterility. The compounded drug cannot be verified as sterile.

    Product
    BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0259-2023·2023-01-18

    Sweet Potato Biscuits Recalled Due to Unlabeled Milk and Wheat Allergens

    Hippos and Hashbrowns is recalling Take & Bake Sweet Potato Biscuits due to missing allergen labels for milk and wheat. Approximately 158 units were distributed in Texas.

    Product
    Take & Bake Sweet Potato Biscuits 44216-26522 packaged in metal tin with clear plastic nonflexible lid
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0935-2023·2023-01-18

    PICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility

    Stradis Healthcare is recalling PICC Kits due to potential pinhole leaks in the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.

    Product
    PICC KIT, 10/CS, ACCESS MEDICAL LABEL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0260-2023·2023-01-18

    Take & Bake Maple Pecan Biscuits recalled for missing allergen labels

    Hippos and Hashbrowns is recalling Take & Bake Maple Pecan Biscuits sold in Texas because the product labels fail to declare milk and wheat allergens. Consumers with allergies should not consume this product.

    Product
    Take & Bake Maple Pecan Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0945-2023·2023-01-18

    Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches

    Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.

    Product
    Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2023·2023-01-18

    PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk

    Stradis Healthcare recalls PHS Lacertaion Tray sterile surgical kits due to potential pinhole leaks in outer packaging near the seal that could compromise sterility. 300 units affected across 10 US states.

    Product
    PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide