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.

5451–5475 of 52957

  • HighFDA (Devices)·Z-1098-2025·2025-02-12

    Surgical sutures recalled for potential sterility breach

    Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.

    Product
    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0498-2025·2025-02-12

    FGF LLC Just Baked Cake Rings Recalled for Potential Listeria Contamination

    FGF, LLC recalls approximately 2,017,614 cases of Just Baked Cake Rings distributed nationwide due to potential contamination with Listeria monocytogenes.

    Product
    item 8201859 JUST BAKED CAKE RING 144x2.45 OZ, NET WT 22.05 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2025·2025-02-12

    Newborn Resuscitator Kit Recalled for Inline Spring Defect

    414 newborn resuscitator kits (ROi CPS LLC) recalled for a potential spring defect in the Inline Controller that could prevent proper ventilation pressure in labor and delivery settings.

    Product
    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1115-2025·2025-02-12

    Beckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors

    Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0488-2025·2025-02-12

    Yeast Ring Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling 2,017,614 cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    item 8201836 GEN YST RING DONUT ZGT PFD 78x3OZ, NET WT 13.16 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-0501-2025·2025-02-12

    FGF LLC Recalls Just Baked Coffee Rolls Over Listeria Contamination Risk

    FGF LLC is recalling 2,017,614 cases of Just Baked Coffee Rolls (78 x 3oz packages) due to potential Listeria monocytogenes contamination. The affected product was produced on or before 12/13/24 and distributed nationwide in the US and Canada.

    Product
    item 8201864 JUST BAKED COFFEE ROLLS 78x3OZ, NET WT 14.62 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0494-2025·2025-02-12

    Frozen donuts recalled nationwide for potential listeria contamination

    FGF, LLC is recalling frozen donuts nationwide due to potential contamination with listeria monocytogenes. Affected products were produced on or before December 13, 2024.

    Product
    item 8201845 GEN RG HEX DONUT DGH FRZ 144x1.88OZ, NET WT 15.23 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0493-2025·2025-02-12

    Frozen Persian Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling frozen Persian donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201844 GEN GLD PERSIAN DONUT DGH FRZ 132x2.5OZ, NET WT 18.56 LB
    Category
    Food
    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
    2 states
  • 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 (Food)·F-0489-2025·2025-02-12

    FGF Yeast Ring Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling over 2 million cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    item 8201839 PBX YST RING DONUT PFD 108x2.12OZ, NET WT 12.88 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0487-2025·2025-02-12

    JUST BAKED Yeast Munchkins Recalled for Potential Listeria Contamination

    FGF, LLC is recalling JUST BAKED Yeast Munchkins nationwide due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    item 8201835 JUST BAKED YEAST MUNCHKINS 350x0.39 OZ, NET WT 8.49 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0219-2025·2025-02-12

    Hydralazine Hydrochloride Tablets Recalled Due to Impurities and Degradation

    SKY Packaging recalls Hydralazine Hydrochloride 25 mg tablets nationwide due to failed quality specifications for impurities and degradation.

    Product
    HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0480-2025·2025-02-12

    French Crullers Recalled Nationwide for Potential Listeria Contamination

    FGF, LLC is recalling French Crullers sold nationwide and in Canada due to potential Listeria monocytogenes contamination. All product with expiration dates from 12/13/24 and earlier is affected.

    Product
    item 8201812 FRENCH CRULLERS 72x 1.6 OZ, NET WT 6.48 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0517-2025·2025-02-12

    FGF Chocolate Cake Rings Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of JUST BAKED Chocolate Cake Rings distributed nationwide in the US and Canada due to potential Listeria monocytogenes contamination.

    Product
    item 8201904 JUST BAKED CHOCOLATE CAKE RINGS ARTIFICIALLY FLAVORED 144x2.5OZ, NET WT 22.5 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0471-2025·2025-02-12

    Chocolate Donut Rings Recalled for Potential Listeria Contamination

    FGF, LLC is recalling chocolate-coated donut rings nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected. No illnesses have been reported.

    Product
    item 8201780 GEN CHOC CK DONUT RINGS PFD 90x2.5OZ, NET WT12.66LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0509-2025·2025-02-12

    Pumpkin-shaped donuts recalled for potential Listeria contamination

    FGF, LLC is recalling pumpkin-shaped donuts distributed nationwide due to potential contamination with Listeria monocytogenes. Consumers should not consume the product.

    Product
    item 8201876 PMPKN SHAPE DONUT ZGT PFD 84x1.75OZ, NET WT 8.27 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0529-2025·2025-02-12

    FGF Vanilla Mini Cake Donut Rings Recalled for Listeria Contamination Risk

    FGF, LLC is recalling 2,017,614 cases of vanilla mini cake donut rings due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024, and distributed nationwide in the US and Canada.

    Product
    item 8202891 PLAIN VANILLA MINI CAKE DONUT RING BULK 240X1.25OZ, NET WT 16.88 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2025·2025-02-12

    Finger entrapment hazard in Philips Allura fluoroscopy patient tables

    Philips is recalling AD7 and AD7X patient tables from Allura and Azurion fluoroscopy systems. During manual repositioning, fingers can become trapped between the guiding rails and tabletop, potentially causing injury.

    Product
    Allura Xper FD20/20 System Code: (1) 722038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2025·2025-02-12

    IntelliVue Patient Monitor MX550 May Fail to Alarm on Ventilator Disconnection

    Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.

    Product
    IntelliVue Patient Monitor MX550. Model Number: 866066
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·25V082000·2025-02-12

    Volkswagen Tiguan camera control units may error at vehicle startup

    Volkswagen is recalling certain Tiguan, Arteon and Audi Q3 vehicles because a camera control unit error at startup may prevent the rearview image displaying.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI TIGUAN, ARTEON, Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V075000·2025-02-10

    Winnebago LP tank mounting fasteners may be improperly tightened

    Winnebago is recalling certain 2025 recreational vehicles because the LP tank mounting bracket fasteners may have been improperly tightened, causing the tank to detach.

    Product
    WINNEBAGO — WINNEBAGO SPIRIT, NAVION, MINNIE WINNIE, VITA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V073000·2025-02-07

    Nikola TRE FCEV Hydrogen Tank Mounting Bolts May Cause Fuel Leak

    Nikola is recalling certain 2024–2025 TRE FCEV trucks because hydrogen tank mounting block bolts may be too long and damage the tank, creating a fire risk.

    Product
    NIKOLA — NIKOLA TRE FCEV
    Category
    Vehicle
    Distribution
    Distributed nationwide