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.

26976–27000 of 50462

  • HighFDA (Food)·F-0400-2019·2018-11-14

    Request Foods Recalls Beecher's Mariachi Mac & Cheese Due to Contamination Risk

    Request Foods Incorporated is recalling Beecher's Mariachi Mac & Cheese because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Beecher's Mariachi Mac & Cheese 20oz. UPC 82045 11274 Frozen 8, 20oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0374-2019·2018-11-14

    Request Foods Recalls Evol Butternut Squash & Sage Ravioli

    Request Foods Incorporated is recalling Evol Butternut Squash & Sage Ravioli due to possible contamination with Listeria monocytogenes and Salmonella.

    Product
    Evol Butternut Squash & Sage Ravioli 8oz. UPC 98997 80974 Frozen 6, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0366-2019·2018-11-14

    Tropical Dreams Ice Cream Recalled for Undeclared Soy and Coconut Allergens

    Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream in Hawaii because soy oil and coconut were not declared on the label.

    Product
    Tropical Dreams Super Premium Ice Cream Chocolate Coconut Macadamia Nut; Pint container; UPC 7 18122 41477 2 Ingredients: Cream, Sugar, Skim milk powder, water, cocoa powder, dark chocolate, pure vanilla, macadamia nuts, corn syrup, barley malt, carob bean gum and guar gum…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0235-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 37.5 mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0410-2019·2018-11-14

    Nutranext Recalls Colon Cleansing Kit Ginger Due to Lead Levels

    Nutranext Business LLC is recalling Colon Cleansing Kit Ginger products because routine testing found elevated lead levels that may pose health risks.

    Product
    Colon Cleansing Kit Ginger
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0396-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 11,580 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The devices are used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0231-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 100mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2019·2018-11-14

    Avella Recalls Bevacizumab Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley is recalling 911 pre-filled Bevacizumab syringes due to a lack of assurance of sterility. The product was distributed throughout the United States.

    Product
    BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0384-2019·2018-11-14

    BD Nexiva IV Catheter Recall Due to Needle Shield Failure

    Becton Dickinson is recalling 133,230 units of BD Nexiva Closed IV Catheter Systems because a needle shield defect may increase the risk of contaminated needlestick injuries.

    Product
    BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0386-2019·2018-11-14

    Request Foods Recalls Kashi Sweet Potato Quinoa Bowls for Contamination

    Request Foods Incorporated is recalling Kashi Sweet Potato Quinoa Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Sweet Potato Quinoa Bowl 9oz. UPC 18627 10547 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0404-2019·2018-11-14

    Request Foods Recalls Vegetable Egg & Cheese Frittata for Listeria and Salmonella

    Request Foods Incorporated is recalling specific lots of Gordon Choice Vegetable Egg & Cheese Frittata due to possible contamination with Listeria monocytogenes and Salmonella.

    Product
    Gordon Choice / GFS Vegetable Egg & Cheese Frittata 60oz. UPC 93901 19112 Frozen 4 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0401-2019·2018-11-14

    Request Foods Recalls Beecher's Enchilada Bowls Due to Contamination Risk

    Request Foods Incorporated is recalling Beecher's Enchilada Bowl Blanco frozen units because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Beecher's Enchilada Bowl Blanco 9oz. UPC 82045 11381 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0407-2019·2018-11-14

    Bake One Recalls Pre Proof Danish Due to Plastic Contamination

    Bake One, Inc. is recalling Pre Proof Danish products because the firm found what appeared to be plastic in the product.

    Product
    Pre Proof Danish Net Wt: 13.7lbs (6.2Kg) Contains: Eggs, Milk, Soy and Wheat KEEP FROZEN AT 0 F OR BELOW Bake One, Inc. Smyrna, GA 30082 UPC 8 10509 01152 6
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0398-2019·2018-11-14

    Request Foods Recalls Jackfruit Bowls Due to Listeria and Salmonella Risk

    Request Foods Incorporated is recalling The Jackfruit Company Enchilada Jackfruit Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    The Jackfruit Company Enchilada Jackfruit Bowl 9.5oz. UPC 59806 00341 Frozen 6, 9.5oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2019·2018-11-14

    Siemens Dimension Thermal Chamber Motor Cable Recall for Insulation Defect

    Siemens is recalling 277 Dimension thermal chamber motor cables worldwide due to single insulation instead of required double insulation, posing a potential electrical shock risk.

    Product
    Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 12,825 units of the RapidFlap System 12mm SpinDown Clamp because the nut was assembled incorrectly. The defect affects sterile clamps used for craniotomy bone flap re-attachment.

    Product
    Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 18mg pellets because the company cannot assure the sterility of the product. The recall covers specific vial sizes distributed nationwide.

    Product
    Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2019·2018-11-14

    Becton Dickinson Recalls PCEA Administration Sets Due to Potential Leaks

    Becton Dickinson is recalling PCEA Administration Sets because they may leak at the connection point. The recall covers 566,737 units distributed worldwide.

    Product
    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0383-2019·2018-11-14

    Request Foods Recalls Evol Butternut Squash Lasagna Due to Contamination Risk

    Request Foods Incorporated is recalling Evol Butternut Squash Lasagna because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Butternut Squash Lasagna 10.8oz. UPC 91627 00794 Frozen 8, 10.8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2019·2018-11-14

    Medtronic CareLink 2090 Programmer Recalled for Software Vulnerability

    Medtronic is recalling CareLink 2090 Programmers worldwide due to a vulnerability that allows unauthorized software updates during the SDN download process.

    Product
    Medtronic CareLink 2090 Programmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0385-2019·2018-11-14

    Request Foods Recalls Kashi Chimichurri Quinoa Bowls for Listeria and Salmonella

    Request Foods Incorporated is recalling Kashi Chimichurri Quinoa Bowls because ingredients were possibly contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi,Chimichurri Quinoa Bowl 9oz. UPC 18627 10440 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V803000·2018-11-14

    Volkswagen and Audi Recall 2018 Models for Rear Seat Weld Defect

    Volkswagen and Audi are recalling 2018 e-Golf, Golf R, A3, and RS3 vehicles because incorrectly welded rear seat head restraint guide sleeves may reduce stability in a crash.

    Product
    AUDI — AUDI, VOLKSWAGEN A3 CABRIOLET, GOLF R, RS 3, E-GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide