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.

14626–14650 of 53092

  • HighNHTSA·23V028000·2023-01-25

    2022 Hyundai Santa Fe Plug-In Hybrid fuel tank defect recall

    Hyundai is recalling certain 2022 Santa Fe Plug-In Hybrid vehicles due to improperly molded fuel tanks that may leak gasoline. A fuel leak in the presence of an ignition source can increase the risk of fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2023·2023-01-25

    FDA Recalls Thoracic Stent-Graft Systems Over Manufacturing Size Defect

    Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0264-2023·2023-01-25

    Klosterman 100% Whole Wheat Breads Recalled for Insanitary Conditions

    Klosterman Baking Company is recalling 100% whole wheat breads distributed in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions. Affected breads were delivered between December 12-16, 2022.

    Product
    Breads: 100% whole wheat product 1415 Klosterman Retail UPC # 0005172100367 Loaf 1 12 oz. 100% whole wheat product 1448 Klosterman Retail UPC # 0005172100401 Loaf 1 24 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0984-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects

    Cardinal Health is recalling 2,277 Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. These defects may affect the drain's function and clinical performance.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0273-2023·2023-01-25

    French Bread Products Recalled for Insanitary Holding Conditions

    Klosterman Baking Company is recalling French bread products (16 oz. loaves, SKUs 8510, 8550, 8551) distributed in Indiana, Ohio, and Tennessee because they were held under insanitary conditions.

    Product
    Breads: Frenchbread product 8510 Clear Bag Loaf 1 16 oz. Frenchbread product 8550 Clear Bag Loaf 1 16 oz. Frenchbread product 8551 Clear Bag Loaf 6 16 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0288-2023·2023-01-25

    Klosterman whole grain breads recalled for insanitary storage conditions

    Klosterman Baking Company is recalling 109,343 units of whole grain breads and baked goods sold in Indiana, Ohio, and Tennessee that were held under insanitary conditions. Products were delivered between December 12-16, 2022.

    Product
    Breads: Whole grain product 1290 Clear Bag Loaf 1 24 oz. Whole grain product 1292 Clear Bag Loaf 1 24 oz. Whole grain product 3474 Clear Bag Buns 12 60 g Whole grain product 3478 Clear Film Buns 60 60 g Whole grain product 3709 Clear Bag Buns 12 1.75 oz. Whole grain…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0994-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Multiple Defects

    Cardinal Health recalls Jackson-Pratt Channel Drains due to reported defects including non-visibility on imaging, dull insertion trocars, reduced flexibility, and broken drain tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling 750 units of Jackson-Pratt Channel Drains (10 mm) due to multiple performance issues including broken drain tips, lack of radiopacity, dull trocars, and reduced flexibility that could affect surgical outcomes.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain: Multiple Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple reported performance defects including dull trocars, lack of flexibility, missing radiopacity, and broken tips. These issues may compromise insertion and drain function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health Jackson-Pratt Channel Drains are recalled for performance defects including dull trocars, broken tips, lack of flexibility, and lack of radiopacity. 220 units are affected.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2023·2023-01-25

    Vasoshield Syringe Ink Chips May Cause Embolic Events

    Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.

    Product
    Hemopro 2 with Vasoshield, Model VH-4001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0304-2023·2023-01-25

    Superior Fresh Spring Mix Recalled for Glass Particle Contamination

    Superior Fresh is recalling Spring Mix lettuce products that may contain small glass particles. The affected packages were distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Lettuce Blend Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf, Butter lettuce, Arugula, spinach. Keep Refrigerated. Packaged under the following Names and sizes: 1. Spring Mix Family Pack Net Wt. 8 oz…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0986-2023·2023-01-25

    Cardinal Health Jackson-Pratt Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (15 Fr, REF JP-2228) due to multiple performance issues including dull trocars, broken wound tips, lack of radiopacity, and inflexibility. The recall affects approximately 15,493 units distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain recalled for performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm, model JP-2212) due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2023·2023-01-25

    Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0279-2023·2023-01-25

    Klosterman Baking Company onion buns and bread recalled for insanitary storage

    Klosterman Baking Company is recalling onion buns and bread distributed in Indiana, Ohio, and Tennessee for products held under insanitary conditions. Consumers should discard affected items.

    Product
    Breads: Onion product 3655 Clear Film Buns 20 69 g
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23V027000·2023-01-25

    2022 Kia Sorento PHEV fuel tank defect fire risk

    Kia is recalling certain 2022 Sorento Plug-In Hybrid vehicles due to improperly molded fuel tanks that may leak. A fuel leak near an ignition source could increase the risk of fire.

    Product
    KIA — KIA SORENTO PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2023·2023-01-25

    Prescription Rifampin Capsules Recalled Due to Failed Quality Specifications

    Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0286-2023·2023-01-25

    Klosterman Wheat Bread Loaves Recalled for Insanitary Storage Conditions

    Klosterman Baking Company is recalling approximately 109,343 wheat bread loaves distributed in Indiana, Ohio, and Tennessee that were held under insanitary conditions, creating a potential contamination risk.

    Product
    Breads: Wheat product 1305 Klosterman Foodservice UPC # 0005172100452 Loaf 1 28 oz. Wheat product 1306 Clear Bag Loaf 1 32 oz. Wheat product 1310 Clear Bag Loaf 1 24 oz. Wheat product 1358 Klosterman Retail UPC # 0005172100714 Loaf 1 24 oz. Wheat product 1380 Pennington…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0985-2023·2023-01-25

    Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The recall affects 7,129 units distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2023·2023-01-25

    Ketorolac Tromethamine ophthalmic solution recalled due to manufacturing deviations

    Akorn is recalling Ketorolac Tromethamine Ophthalmic Solution nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers of the 0.5% formulation.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled due to performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 3,520 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0280-2023·2023-01-25

    Klosterman Baking Company recalls potato flour buns due to insanitary holding conditions

    Klosterman Baking Company is recalling potato flour buns sold in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions that could pose health risks.

    Product
    Breads: Potato flour product 3555 Clear Bag Buns 12 80 g Potato flour product 3561 Clear Film Buns 20 92 g Potato flour product 6057 Clear Bag Buns 24 34 g
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0977-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips that may impair drain function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0281-2023·2023-01-25

    Klosterman Baking Company recalls pretzel buns for insanitary storage conditions

    Klosterman Baking Company is recalling 109,343 pretzel buns due to insanitary storage conditions. Products distributed to Indiana, Ohio, and Tennessee have expiration dates of December 21, 2022 or earlier.

    Product
    Breads: Pretzel product 8309 Clear Bag Buns 48 2.1 oz.
    Category
    Food
    Distribution
    3 states