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.

8351–8375 of 22105

  • HighFDA (Devices)·Z-1093-2025·2025-02-12

    Philips Azurion patient tables recalled for finger entrapment risk

    Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.

    Product
    Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2025·2025-02-12

    FDA Recalls PROLENE Polypropylene Sutures for Defective Packaging Seals

    Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.

    Product
    PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0490-2025·2025-02-12

    Frozen Persian Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling frozen Persian donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    item 8201841 GEN PERSIAN DONUT DGH FRZ 168x2OZ, NET WT 18.90 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0221-2025·2025-02-12

    Potassium Chloride Tablets Recalled for Failed Dissolution Specifications

    The FDA is recalling Potassium Chloride Extended-Release Tablets (10 mEq) distributed nationwide because they failed dissolution tests. This could affect how the medication is released in the body.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2025·2025-02-12

    PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach

    Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.

    Product
    PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0519-2025·2025-02-12

    FGF Cake Sticks Recalled for Potential Listeria Contamination

    FGF cake sticks are being recalled nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not eat the product and should return it to retailers.

    Product
    item 8201906 JUST BAKED CAKE STICKS 116x2.9 OZ, NET WT 21.03 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0512-2025·2025-02-12

    FGF LLC Recalls Unfilled Bismarck Donuts for Listeria Contamination Risk

    FGF LLC is recalling 2,017,614 cases of unfilled Bismarck donuts nationwide due to potential listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    item 8201883 UNFLD BISMARK DONUT PFD 57x2.75OZ, NET WT 8.82 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0513-2025·2025-02-12

    FGF Persian Yeast Donuts Recalled Nationwide for Potential Listeria Contamination

    FGF, LLC is recalling Persian yeast donuts due to potential Listeria monocytogenes contamination. The recall affects all product produced on or before December 13, 2024.

    Product
    item 8201884 PERSIAN YST DONUT PFD 46x3.5 OZ, NET WT 9.06 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0528-2025·2025-02-12

    Unfilled Bismarck Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling over 2 million cases of unfilled Bismarck donuts due to potential Listeria monocytogenes contamination. The recall affects products distributed nationwide in the US and Canada.

    Product
    item 8202731 UNFLD BISMARK DONUT PFD 78X3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2025·2025-02-12

    Sysmex PS-10 Sample Preparation System Recalled for False Test Results

    Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.

    Product
    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0502-2025·2025-02-12

    Just Baked Apple Fritters Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling Just Baked Apple Fritters nationwide due to potential Listeria monocytogenes contamination. Consumers should discard affected products.

    Product
    item 8201865 JUST BAKED APPLE FRITTERS 72x3OZ, NET WT 13.50 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2025·2025-02-12

    Philips Allura CV20 patient tables risk finger entrapment during repositioning

    The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.

    Product
    Allura CV20 System Code: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0524-2025·2025-02-12

    Donut Product Recalled for Potential Listeria Monocytogenes

    FGF, LLC is recalling approximately 2 million cases of its BAV CRM BAR DONUT product nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should dispose of it or return it to the retailer.

    Product
    item 8201923 BAV CRM BAR DONUT PFD 78 X 3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0521-2025·2025-02-12

    FDA Recalls Apple Crisp Cake Donuts for Potential Listeria Contamination

    FGF, LLC recalls Apple Crisp Cake Donuts for potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected.

    Product
    item 8201920 APPLE CRISP CK DONUT PFD 78x3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0496-2025·2025-02-12

    Frozen donuts recalled for potential listeria monocytogenes contamination

    FGF, LLC is recalling frozen donuts nationwide due to potential contamination with listeria monocytogenes. Consumers should not consume the product and should discard or return it.

    Product
    item 8201848 GEN HEX RG DONUT DGH FRZ 96x2.75OZ, NET WT 14.86 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2025·2025-02-12

    ECG cable shipped with incomplete cleaning and disinfection instructions

    Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.

    Product
    LIFEPAK 35 ECG cable REF 11111-000041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0465-2025·2025-02-12

    FDA Recalls Greenwise Organic Pecan Halves for Undeclared Walnuts

    The FDA has recalled Greenwise Organic Pecan Halves (8-ounce bags) due to undeclared walnuts, a major allergen. The affected product was distributed in eight southeastern states.

    Product
    Greenwise Organic Pecan Halves 8 ounce, plastic printed package marked with lot # 18228 and with a best by date of April.23.2025 stamped on front UPC: 041415212336
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1095-2025·2025-02-12

    Hologic Rapid fFN Specimen Collection Tubes May Contain Incorrect Extraction Buffer Volumes

    Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.

    Product
    The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V901000·2025-02-12

    2024 Hyundai Kona: Battery Cable Chafing May Cause Engine Fire

    Hyundai is recalling 2024 Kona vehicles because battery cables may chafe and short circuit, increasing the risk of engine compartment fire. Dealers will install protective sheathing at no cost.

    Product
    HYUNDAI — 2024 HYUNDAI KONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2025·2025-02-12

    Medical X-Ray System Permits Bypass of Radiation Exposure Control

    GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.

    Product
    Discovery XR656HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2025·2025-02-12

    IntelliVue Patient Monitor MX500 may fail to generate critical alarms

    Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.

    Product
    IntelliVue Patient Monitor MX500. Model Number: 866064
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V860000·2025-02-11

    2022 Indian FTR1200 Motorcycles Recalled for Fuel Tank Leak Risk

    Indian Motorcycle Company is recalling certain 2022 FTR1200 motorcycles due to fuel tanks with holes that may leak fuel, increasing the risk of fire or injury. Dealers will replace the fuel tank free of charge.

    Product
    INDIAN — 2022 INDIAN FTR1200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V723000·2025-02-10

    2024 Subaru Forester Water Pipe Bolts May Loosen, Risk Fire

    Certain 2024 Subaru Forester models have engine water pipe attachment bolts that may loosen, allowing the pipe to leak coolant onto hot engine components and create a fire risk.

    Product
    SUBARU — 2024 SUBARU FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V716000·2025-02-10

    Third-row seatbelt buckle defect in 2022–2024 Jeep Wagoneer models

    Chrysler is recalling 2022–2024 Jeep Wagoneer and Grand Wagoneer vehicles because the third-row seatbelt buckles may not fasten properly. Unfastened seatbelts could increase injury risk during a crash.

    Product
    JEEP — 2022 JEEP WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide