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.

3951–3975 of 52939

  • HighFDA (Devices)·Z-2230-2025·2025-08-06

    RAPIDPoint 500 wash waste cartridge lot biases seven blood analytes

    A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.

    Product
    RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0352-2025·2025-08-06

    Blue fin tuna processed under insanitary conditions in Georgia facility

    Blue Fin Tuna sold in 50 lb boxes is being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture. 59 lb affected.

    Product
    Blue Fin Tuna, Net WT (variable weight) 50 lb brown corrugated carboard box. Boxes contain ice for temperature control. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2220-2025·2025-08-06

    Celsior cold storage solution recalled over sterility assurance during aseptic manufacturing

    Celsior Cold Storage Solution is being recalled because of the potential risk of microbiological contamination due to an inability to ensure sterility assurance throughout aseptic manufacturing. 1,532 units affected.

    Product
    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2174-2025·2025-08-06

    HeartSine samaritan public access defibrillators may not deliver shocks properly

    HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2025·2025-08-06

    SwabFlush prefilled syringes carry SwabCaps with a compromised seal

    SwabFlush Prefilled Syringes with ICU Medical SwabCaps are being recalled because a manufacturing issue affects the SwabCap seal, which may reduce disinfection of the luer access valve. 1,427,100 units affected.

    Product
    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2025·2025-08-06

    Blood EMB Levine plates may carry Listeria monocytogenes contamination

    Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.

    Product
    Blood/EMB, Levine 100/PK, Product Number R02041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2025·2025-08-06

    Blood MacConkey biplates may carry Listeria monocytogenes surface contamination

    Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 units are affected.

    Product
    Blood/MacConkey Biplate 100/PK, Product Number R02049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0371-2025·2025-08-06

    Reisman's cinnamon wrap recalled over undeclared wheat and soy

    Reisman's Cinnamon Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Cinnamon Wrap 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·H-0367-2025·2025-08-06

    Reisman's chocolate danishes recalled over undeclared wheat and soy

    Reisman's Chocolate Danishes 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Danishes 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2223-2025·2025-08-06

    Blood agar plates may carry Listeria monocytogenes surface contamination

    Blood Agar with 5% Sheep Blood, product number R01202, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 1,552 units affected.

    Product
    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0370-2025·2025-08-06

    Reisman's chocolate wrap recalled over undeclared wheat and soy

    Reisman's Chocolate Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Wrap 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2200-2025·2025-08-06

    Philips Achieva 3.0T gradient coils may act as a heat source

    Achieva 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 460 units are affected.

    Product
    Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2025·2025-08-06

    Philips Evolution Upgrade 3.0T gradient coils may act as heat source

    Evolution Upgrade 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 50 units are affected.

    Product
    Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0353-2025·2025-08-06

    Yellow fin tuna processed under insanitary conditions in Georgia facility

    Yellow Fin Tuna sold in 50 lb boxes is being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture. 68.10 lb affected.

    Product
    Yellow Fin Tuna, Net WT (variable weight) 50 lb brown corrugated carboard box. Boxes contain ice for temperature control. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2210-2025·2025-08-06

    Philips Ingenia Elition S gradient coils may act as a heat source

    Ingenia Elition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 242 units are affected.

    Product
    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0354-2025·2025-08-06

    Bunge European style butter blend recalled over undeclared milk allergen

    NH European Style Butter Blend from Bunge, 1 lb blocks, is being recalled because of undeclared milk. 64,800 pounds across 1,800 cases are affected.

    Product
    NH EUROPEAN STYLE BUTTER BLEND, BUNGE, NET WT 1 LB, MFD IN USA BY: Bunge Oils, Chesterfield, MO 63017, packed in white paperboard cases (36 blocks to a case) OW NH EURO BLEND SOLIDS 2015918
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·H-0359-2025·2025-08-06

    Reisman's brownie bars recalled over undeclared wheat and soy

    Reisman's Brownie Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Brownie Bars 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2215-2025·2025-08-06

    SmartPath to dStream 3.0T gradient coils may act as heat source

    SmartPath to dStream for 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 15 units affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2025·2025-08-06

    Philips Ingenia Ambition X gradient coils may act as heat source

    Ingenia Ambition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 690 units are affected.

    Product
    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0376-2025·2025-08-06

    Reisman's chocolate babka slices recalled over undeclared wheat and soy

    Reisman's Chocolate Babka Slices 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.

    Product
    Reisman's Chocolate Babka Slices 3 oz.
    Category
    Food
    Distribution
    9 states
  • HighNHTSA·25E049000·2025-08-05

    Holley Recalls 140 GPH Electric Fuel Pumps Due to Methanol Incompatibility

    Holley Performance Products is recalling 140 GPH BLACK electric fuel pumps because they may not be compatible with methanol fuel, which can cause leaks and fire risks.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V499000·2025-08-04

    2024-2025 Winnebago Ekko RV Tire Valve Extension Defect Recall

    Winnebago is recalling certain 2024-2025 Ekko recreational vehicles due to damaged tire valve extensions that can cause air loss in the inner tire and overload the outer tire, creating a crash risk. Dealers will replace the extensions free of charge.

    Product
    WINNEBAGO — WINNEBAGO EKKO
    Category
    Vehicle
    Distribution
    Distributed nationwide