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.

15576–15600 of 53092

  • HighNHTSA·22V804000·2022-10-26

    Rearview camera display malfunction in 2022 Lamborghini Urus vehicles

    The infotainment system in certain 2022 Lamborghini Urus vehicles may become damaged, causing the rearview camera display to become inoperative. This reduces rear visibility and increases the risk of a crash.

    Product
    LAMBORGHINI — LAMBORGHINI URUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0066-2023·2022-10-26

    Mrs. Freshley's Cherry Fruit Pie recalled for undeclared soy lecithin

    Flowers Foods is recalling Mrs. Freshley's Cherry Fruit Pie due to undeclared soy lecithin. Soy is a major allergen; consumers with soy allergies should not consume the product.

    Product
    Mrs. Freshley's Cherry Fruit Pie NET WT 4.5 OZ (128g) UPC 0 72250 0081 0 DISTRIBUTED BY FLOWERS FOODS SPECIALTY GROUP, LLC, 5987 SOUTH ROYAL ATLANTA DR, TUCKER, GA 30084
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0046-2023·2022-10-26

    Nick's Krispi Nougat Protein Bar Recalled for Undeclared Hazelnut

    Nick's Krispi Nougat Protein Bar is being recalled because the product contains hazelnuts that are not declared on the label. This poses a risk to consumers with tree nut allergies.

    Product
    Nick's Krispi Nougat Protein Bar, 1.76 oz., in foil wrapper in 12 pack boxes. UPC: 00850009682345 Product of North Macedonia Distributed by LUB Foods USA, Inc. El Segundo, CA 90245
    Category
    Food
    Distribution
    12 states
  • HighNHTSA·22V806000·2022-10-26

    Multiple 2021-2022 Audi models recalled for rearview camera failure

    Volkswagen Group of America is recalling certain 2021-2022 Audi vehicles. The infotainment system may fail to display the rearview camera, reducing rear visibility and increasing crash risk.

    Product
    AUDI — AUDI RS Q8, S5 CABRIOLET, E-TRON GT, A3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2023·2022-10-26

    Acyclovir Sodium Injectable Recalled for Particulate Matter

    AuroMedics Pharma is recalling Acyclovir Sodium injection due to dark red, brown, and black particulate matter found in vials. Approximately 89,400 vials were distributed nationwide.

    Product
    ACYCLOVIR SODIUM — ACYCLOVIR SODIUM (ACYCLOVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0062-2023·2022-10-26

    Lyons Ready Care Thickened Apple Juice Recalled for Spoilage Indication

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Apple Juice due to indication of product spoilage. The recall affects 320 cases distributed nationwide.

    Product
    Lyons Ready Care Thickened Apple Juice packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • HighFDA (Devices)·Z-0110-2023·2022-10-26

    Oral Tip Syringes Recalled Due to Unapproved Plunger Material

    Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.

    Product
    Medicina Oral Tip Syringe 1ml Code: OT01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2023·2022-10-26

    ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk

    B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.

    Product
    ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2023·2022-10-26

    Lithium diagnostic assay may display falsely elevated results on Atellica CH analyzer

    The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.

    Product
    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2023·2022-10-26

    Medicina Oral Tip Syringe Recall Due to Unapproved Plunger Material

    Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The syringes do not meet raw material specifications.

    Product
    Medicina Oral Tip Syringe 0.5ml Code: OT005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0096-2023·2022-10-26

    Laryngeal mask airway recalled for incorrect size marking

    Intersurgical Solus Standard size 3 laryngeal mask airways are marked with incorrect size 4 information, which may cause misuse or improper sizing of the airway device.

    Product
    Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0105-2023·2022-10-26

    Medical device assay may report falsely elevated lithium levels

    Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.

    Product
    Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0011-2023·2022-10-26

    Rifampin Capsules recalled due to excessive impurity levels

    Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 300 mg, because samples exceeded acceptable limits for 1-Methyl-4-Nitrosopoperazine (MNP), an impurity. Multiple lot numbers were distributed nationwide.

    Product
    Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V807000·2022-10-26

    Volkswagen Atlas and Cross Sport trailing arm bolt defect recall

    Volkswagen is recalling certain 2022 Atlas and 2022-2023 Cross Sport vehicles because driver-side rear trailing arm bolts may loosen and fall out, risking loss of vehicle control.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2023·2022-10-26

    DePuy Synthes Hammertoe Implants Recalled for Incorrect Drill Guide Size

    Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.

    Product
    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0051-2023·2022-10-26

    Tuscan Garden Italian Dressing Recalled for Undeclared Soy and Wheat Allergens

    Tuscan Garden Restaurant Style Italian Dressing is being recalled due to undeclared soy and wheat allergens. The recall affects 26,370 mixed cases distributed across 20 states.

    Product
    Tuscan Garden Restaurant Style Italian Dressing , Net 16 FL OZ (1 PT) 473 mL, Plastic Bottle 12 count mixed case containing 3 Dressing flavors, including 8 bottles of the Restaurant Style Italian
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0095-2023·2022-10-26

    BD Vacutainer Blood Alcohol Testing Tubes Recalled for Analytical Interference

    BD Vacutainer blood collection tubes are recalled due to isobutylene contamination that may cause false positive results in blood alcohol testing.

    Product
    BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2023·2022-10-26

    Siemens N Antiserum to Human IgG Recall for High-Dose Performance Failure

    Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.

    Product
    N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0015-2023·2022-10-26

    Saline Solution Injection Recalled Nationwide Due to Sterility and Leakage

    Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection distributed nationwide due to lack of assurance of sterility and potential leakage. Multiple lot numbers with expiration dates ranging from May 2023 to August 2023 are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0047-2023·2022-10-26

    Trader Joe's Organic Tortilla Chip Rounds recalled for undeclared milk and soy

    Trader Joe's Organic Yellow Tortilla Chip Rounds may contain undeclared milk and soy allergens. The product contains small amounts of Spicy Cheese Crunchies which were not listed on the label.

    Product
    16 oz. bags of Trader Joe's Organic Yellow Tortilla Chip Rounds. UPC: 0074-0449 Distributed and Sold exclusively by: Trader Joe's, Monrovia, CA 91016 Distributed and sold exclusively by: Trader Joe's, Monrovia, CA 91016 Distributed and Sold Exclusively By: Trader Joe's…
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-0097-2023·2022-10-26

    Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies

    Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.

    Product
    cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0091-2023·2022-10-26

    IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk

    B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.

    Product
    Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0053-2023·2022-10-26

    Lyons Ready Care Thickened Orange Nectar Recalled for Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Orange Nectar due to indication of product spoilage. The recall affects 1,272 cases distributed nationwide with specific lot numbers and best-by dates in March 2023.

    Product
    Lyons Ready Care Thickened Orange Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • HighFDA (Food)·F-0064-2023·2022-10-26

    Nestle Cookie Dough Recalled for Plastic Contamination

    Nestle-USA is recalling Stuffed Chocolate Chip Cookie Dough due to consumer complaints of white plastic pieces found in the product. Consumers should not eat the product.

    Product
    "***Nestle***STUFFED***CHOCOLATE CHIP COOKIE DOUGH***4 JUMBO COOKIES***NET WT 8 OZ***"
    Category
    Food
    Distribution
    40 states
  • HighFDA (Food)·F-0057-2023·2022-10-26

    Lyons Ready Care Thickened Sweet Tea Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Sweet Tea with Lemon Nectar due to indication of product spoilage. Approximately 491 cases were distributed across all U.S. states.

    Product
    Lyons Ready Care Thickened Sweet Tea with Lemon Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states