The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

3026–3050 of 3531

  • ModerateFDA (Devices)·Z-0438-2022·2022-01-05

    VIDAS SARS-CoV-2 IgM Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling one lot of VIDAS SARS-CoV-2 IgM tests nationwide due to a substrate defect that prevents the test from running. The defect causes delayed results as users must repeat testing.

    Product
    VIDAS SARS-COV-2 IgM, Ref 423833-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0436-2022·2022-01-05

    VIDAS Lyme IgM II Diagnostic Test Kits Recalled for Substrate Error

    bioMerieux is recalling three lots of VIDAS Lyme IgM II diagnostic test kits due to a substrate error that prevents the test from running, requiring users to conduct another test to obtain results.

    Product
    VIDAS Lyme IgM II (LYM), REF 416436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2022·2022-01-05

    FDA Recalls VIDAS PRG Progesterone Test Kits for Substrate Error

    bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone test kits due to a substrate error that prevents the tests from running properly, causing delayed results when patients need repeat testing.

    Product
    VIDAS PRG Progesterone, REF 30409-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2022·2022-01-05

    Diagnostic test kit recalled due to substrate error preventing test execution

    A diagnostic test kit manufactured by bioMerieux has been recalled because a substrate error prevents the test from running, which delays test results for patients.

    Product
    VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2022·2022-01-05

    VIDAS RUB IgG Diagnostic Test Kit Recalled for Substrate Defect

    bioMerieux is recalling three lots of VIDAS RUB IgG test kits due to substrate errors that prevent the test from running, potentially delaying diagnostic results.

    Product
    VIDAS RUB IgG (RBG), REF 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0427-2022·2022-01-05

    Diagnostic substrate error in medical testing device causes test failures

    bioMerieux is recalling 1,579 VIDAS DEX@ diagnostic devices due to substrate errors that prevent test execution, requiring users to rerun tests and potentially delaying results.

    Product
    VIDAS DEX@, Dimer Exclusion II, REF 30455-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2022·2022-01-05

    Diagnostic device recall: incorrect color in package insert reading table

    Biomerieux is recalling RAPID 20 E diagnostic systems because the package insert contains an incorrect color for interpreting negative CIT test results.

    Product
    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0335-2022·2021-12-29

    Coca-Cola Cola 12-Pack Recalled for Potential Foreign Matter

    COCA COLA Consolidated LLC is recalling Coca-Cola cola in 12 oz. aluminum cans (12-pack fridge packs) distributed to Arkansas, Mississippi, and Tennessee due to the potential presence of foreign matter in containers.

    Product
    Coca-Cola cola; 12 oz. aluminum can; 12-pack fridge pack/case
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0309-2022·2021-12-29

    Freshness Guaranteed Black Forest Tiny Pies recalled for potential metal contamination

    Freshness Guaranteed Black Forest Tiny Pies 18.5 oz. are being recalled nationwide due to potential metal in the product. Consumers should not eat the product and should contact the manufacturer or retailer.

    Product
    Freshness Guaranteed Black Forest Tiny Pies 18.5 oz. UPC 0 78742 37635 6
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0343-2022·2021-12-29

    Cesarina Cookies Recalled Due to Undeclared Milk

    Cesarina Bakery, Inc. is recalling Cesarina Cookies, Fiochetto, Apricot Raspberry Guava (16oz boxes) because they contain undeclared milk, a common allergen. The recall affects domestic distribution and applies to multiple lot codes with expiration dates ranging from March 2022 through May 2022.

    Product
    Cesarina Cookies, Fiochetto, Apricot Raspberry Guava, Net Weight 16oz (453.59g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0404-2022·2021-12-29

    Stanbio TDM/B-Hydroxybutyrate Controls Recalled Due to Improper Storage Temperature

    Medline Industries is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls due to improper storage conditions. The product was shipped at room temperature instead of the required refrigerated environment.

    Product
    Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0318-2022·2021-12-29

    Black Rifle Coffee Mac V Whole Bean Coffee Recalled for Possible Plastic Contamination

    Black Rifle Coffee Company is recalling Black Rifle Coffee Mac V Whole Bean Coffee 12oz bags due to the possible presence of plastic within the final product packaging. The affected product was distributed in Tennessee.

    Product
    Black Rifle Coffee Mac V Whole Bean Coffee 12oz PET bags 40 bags per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0316-2022·2021-12-29

    Kimberley's Bakeshoppe Sugar Cookies Recalled for Potential Metal Contamination

    GIVE AND GO is recalling Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cookies (9.4 oz., UPC 7 70981 30312 3) nationwide due to potential metal in the product.

    Product
    Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cookies 9.4 oz. UPC 7 70981 30312 3
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0287-2022·2021-12-29

    Medline Hand Sanitizer Foam Recalled for Defective Containers

    Medline Industries Inc is recalling Hand Sanitizer Foam in multiple sizes due to leaking bottles and dispensing issues reported by customers. The product was distributed nationwide and internationally.

    Product
    Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2022·2021-12-29

    VirtuTRAX Instrument Navigator recalled for potential tightening failure

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential defect that may prevent proper tightening onto medical instruments. The device was distributed worldwide.

    Product
    VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0289-2022·2021-12-29

    Fexofenadine Hydrochloride Tablets 60 mg Recalled for Failed Impurities and Degradation Specifications

    The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, distributed by Major Pharmaceuticals nationwide due to failed impurities and degradation specifications. Affected lots are H00005, H00006, and H00007.

    Product
    Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0408-2022·2021-12-29

    Malosa Core Phaco Pack 2 Surgical Kit Recalled for Packaging Sterility Risk

    Beaver Visitec International is recalling the Malosa Core Phaco Pack 2 medical refractive kit due to small holes in the kit packaging that may compromise product sterility.

    Product
    Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-0339-2022·2021-12-29

    Flora Raspberry Pastries Recalled for Undeclared Milk

    Cesarina Bakery is recalling Flora Raspberry Sandwich Pastries because they contain undeclared milk, which poses a risk to consumers with milk allergies. The recall affects 1,028 cases distributed domestically.

    Product
    Flora PASTRIES RASPBERRY SANDWICH Chocolate Dipped with Sprinkles, Net. Wt. 16 oz (454g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0338-2022·2021-12-29

    Flora Pastries Butter Cookies Recalled for Undeclared Milk

    Cesarina Bakery, Inc. is recalling Flora Pastries Butter Cookies because they contain undeclared milk, which poses a hazard to consumers with milk allergies. The recall affects 37 cases distributed domestically.

    Product
    Flora PASTRIES BUTTER COOKIES Assorted Varieties, Net. Wt. 16 oz (454g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0344-2022·2021-12-29

    Cesarina Cookies Tutti Frutti Recalled for Undeclared Milk

    Cesarina Bakery, Inc. is recalling Cesarina Cookies Tutti Frutti (16 oz) because the product contains undeclared milk, a common allergen not listed on the label.

    Product
    Cesarina Cookies, Tutti Frutti Cookies, Net Weight 16oz (453.59g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0290-2022·2021-12-29

    Cupcakes Recalled Due to Potential Metal Contamination

    Give and Go is recalling multiple cupcake products totaling approximately 1.14 million units due to potential metal contamination. Affected products were distributed nationwide.

    Product
    two-bite vanilla & chocolate cupcakes 10 oz. UPC 7 70981 04502 3 20 oz. UPC 7 70981 03107 1 meijer mini assorted cupcakes with Holiday inspired sprinkle blend 20 oz. UPC 7 08820 40243 0 Kimberley's bakeshoppe vanilla & chocolate cupcakes 22 oz. UPC 7 70981 31122 7
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2022·2021-12-29

    Testicular Prosthesis Recalled Due to Incorrect Size Labeling

    Coloplast Manufacturing is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to incorrect size labeling. Nineteen units were distributed in the US and Canada.

    Product
    Torosa Saline-Filled Testicular Prosthesis (Size Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0336-2022·2021-12-29

    Sprite 12 oz. Cans Recalled for Potential Foreign Matter

    Coca Cola Consolidated LLC is recalling Sprite 12 oz. aluminum cans distributed to Arkansas, Mississippi, and Tennessee due to potential foreign matter in containers.

    Product
    Sprite; 12 oz. aluminum can; 12-pack fridge pack/case
    Category
    Food
    Distribution
    3 states
  • ModerateCPSC·22042·2021-12-29

    American Angler Electric Fillet Knives Recalled for Laceration Hazard

    Scott Fetzer Consumer Brands is recalling about 43,200 American Angler Electric Fillet Knives because the trigger mechanism can become stuck in the "on" position, posing a laceration hazard to users.

    Product
    American Angler Electric Fillet Knives
    Category
    Consumer Product
    Distribution
    Distributed nationwide