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.

14651–14675 of 53092

  • HighFDA (Devices)·Z-0982-2023·2023-01-25

    Jackson-Pratt Wound Drain Recalled for Performance Issues

    Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Performance Defects

    Cardinal Health is recalling 1920 Jackson-Pratt Channel Drains (15 Fr, model JP-2233) distributed worldwide due to multiple reported performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0307-2023·2023-01-25

    Superior Fresh Organic Spring Mix Recalled for Glass Particles

    Superior Fresh Organic Raw Spring Mix is being recalled due to small glass particles that may be present in the product. Affected packages have specific Julian date codes and were distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Organic Raw Spring Mix. 1 lb. Bag, 4 Count. UPC 8 57871-00827 3 Keep Refrigerated. Grown for you By: Superior Fresh LLC, Hixton, WI 54635
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0974-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (7 mm, REF JP-2211) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. About 1,768 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0157-2023·2023-01-25

    Prescription Eye Drops Recalled for Manufacturing Control Deviations

    Akorn, Inc. is voluntarily recalling over 2 million bottles of Tobramycin Ophthalmic Solution due to Current Good Manufacturing Practice deviations affecting four product lots distributed nationwide.

    Product
    Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0159-2023·2023-01-25

    Rasagiline Tablets Recalled for Foreign Particle Contamination

    Ascend Laboratories is recalling Rasagiline Mesylate Tablets 1 mg due to black spots and metallic specks on tablets. The recall affects 12,192 bottles distributed to customers in 19 states and Puerto Rico.

    Product
    RASAGILINE — RASAGILINE (RASAGILINE)
    Category
    Drug
    Distribution
    20 states
  • HighFDA (Food)·F-0292-2023·2023-01-25

    Melissa's Pasta Para Duris Recalled for Undeclared Wheat Allergen

    Melissa's Pasta Para Duris is being recalled for containing wheat that is not declared on the label. Anyone with a wheat allergy should discard the product or return it to their retailer.

    Product
    Pasta Para Duris 12 oz. (340g) Brand Name: Melissa's UPC: 045255 152739 Distributed by: World Variety Produce, Inc. PO Box 514599 LA, CA 90051 Clear plastic bag with front label Package size: 6 count
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0957-2023·2023-01-25

    Mobile CT Scanner Injury Risk During Reverse Transport

    Mobius Imaging recalls the MobiCT-32 AIRO Mobile CT Scanner after one untrained user was injured while moving the unit in reverse. The manufacturer will add warning labels to improve instructions for safe reverse transport.

    Product
    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2023·2023-01-25

    Patient table footrest may detach from AXIOM Luminos Agile

    Siemens Medical Solutions is recalling the AXIOM Luminos Agile patient table because the footrest may detach during use, creating a potential injury risk.

    Product
    AXIOM Luminos Agile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0284-2023·2023-01-25

    Klosterman Baking seeded bread and buns held under insanitary conditions

    Klosterman Baking Company recalls seeded bread and bun products held under insanitary conditions. 109,343 units were distributed in Indiana, Ohio, and Tennessee.

    Product
    Breads: Seeded product 3340 Clear Bag Buns 12 60 g Seeded product 3510 Clear Film Buns 30 68 g Seeded product 3600 Clear Bag Buns 12 92 g
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0127-2023·2023-01-25

    Injectable Anesthetic Sensorcaine Recalled for Subpotent Epinephrine

    Sensorcaine injectable anesthetic is being recalled because testing showed the epinephrine component is below the required potency level. No illnesses or injuries have been reported.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling 22,847 units of Jackson-Pratt Channel Drains due to performance issues including dull trocars, broken tips, lack of flexibility, and lack of radiopacity.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2023·2023-01-25

    Jackson-Pratt Surgical Drain Recalled Due to Performance Defects

    Cardinal Health is recalling 4,372 Jackson-Pratt Channel Drains due to multiple performance issues: lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0147-2023·2023-01-25

    Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations

    Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0268-2023·2023-01-25

    Klosterman croissant products recalled for insanitary storage conditions

    Klosterman Baking Company is recalling approximately 109,343 croissant products distributed in Indiana, Ohio, and Tennessee due to insanitary storage conditions. Products were delivered between December 12 and December 16, 2022.

    Product
    Breads: Croissant product 9013 Clear film Croissants 64 2.3 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0285-2023·2023-01-25

    Klosterman Baking Company Sour Dough Bread Recalled for Insanitary Production Conditions

    Klosterman Baking Company is recalling approximately 109,343 units of Sour Dough bread products due to insanitary production conditions. Products were distributed in Indiana, Ohio, and Tennessee.

    Product
    Breads: Sour Dough product 1728 Clear Bag Loaf 1 32 oz. Sour Dough product 1729 Clear Bag Loaf 1 32 oz. Sour Dough product 1979 Clear Bag Loaf 1 24 oz. Sour Dough product 8561 Clear Bag Loaf 1 32 oz. Sour Dough product 8563 Clear Bag Loaf 1 32 oz. Sour Dough product 8566…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0973-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (7mm, REF JP-2210) for performance issues including lack of radiopacity, dull trocars, poor flexibility, and broken tips. Affected units may not function properly.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0275-2023·2023-01-25

    Klosterman Honey Wheat Breads Recalled for Insanitary Storage Conditions

    Klosterman Baking Company recalls honey wheat breads and rolls from Indiana, Ohio, and Tennessee due to products being held under insanitary conditions. Approximately 109,343 units were distributed between December 12-16, 2022.

    Product
    Breads: Honey wheat product 1318 Clear Bag Loaf 1 32 oz. Honey wheat product 1410 Klosterman Retail UPC # 0005172100366 Loaf 1 12 oz. Honey wheat product 8081 Clear Bag Rolls 12 1.4 oz. Honey wheat product 8543 Clear Bag Loaf 1 32 oz. Honey wheat product 8549 Clear Bag Loaf…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0988-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health Jackson-Pratt Channel Drains (19 Fr, REF JP-2230) are recalled due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting 29,515 units.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1002-2023·2023-01-25

    X-ray imaging system footrests may detach from patient tables

    Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.

    Product
    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0276-2023·2023-01-25

    Klosterman Honey White Bread and Buns Recalled for Insanitary Conditions

    Klosterman Baking Company recalls honey white bread and buns held under insanitary conditions. Affected products were distributed in Indiana, Ohio, and Tennessee between December 12-16.

    Product
    Breads: Honey white product 3136 Clear Bag Buns 60 60 g Honey white product 3140 Klosterman Retail UPC # 0005172100106 Buns 12 60 g
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0306-2023·2023-01-25

    Superior Fresh Mighty Mix salad recall: glass particle contamination

    Superior Fresh LLC is recalling Mighty Mix salad mix (4 oz packages, Best By 1/23) due to potential contamination with small glass particles. No injuries have been reported; consumers should discard the product.

    Product
    Superior Fresh Mighty Mix, Net Wt. 4 oz. (113g). UPC 8 57871-00883 9. Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf, Arugula, Mizuna, Pak Choi, Spinach. Keep Refrigerated. Grown for you By: Superior Fresh LLC…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0270-2023·2023-01-25

    Klosterman English Muffins recalled for insanitary storage conditions

    Klosterman Baking Company is recalling English Muffins that were held under insanitary conditions. The recall affects over 109,000 units distributed to Indiana, Ohio, and Tennessee.

    Product
    Breads: English Muffin product 9525 Clear Bag English Muffins 12 2 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0303-2023·2023-01-25

    Superior Fresh Organic Spring Mix Recalled for Glass Particles

    Superior Fresh Organic Spring Mix Family Pack is being recalled due to potential glass particle contamination. The recall affects 1,516 cases distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Organic Spring Mix Family Pack. UPC 8 50038-27430 6. Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf. Keep Refrigerated. Grown for you By: Superior Fresh LLC, Hixton, WI 54635
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0989-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain recall for performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects: dull trocars, broken tips, lack of flexibility, and radiopacity issues. The 8,563 affected units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
    Category
    Medical Device
    Distribution
    Distributed nationwide