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.

5376–5400 of 52957

  • HighFDA (Devices)·Z-1046-2025·2025-02-12

    X-Ray Imaging System May Continue Exposure Beyond Safety Limit

    GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.

    Product
    Optima XR646 HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0506-2025·2025-02-12

    FGF Fluff Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of item 8201870 Fluff Donuts 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 8201870 GEN BAR FLUFF DONUT ZGT PFD 78x3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2025·2025-02-12

    Patient Monitor May Fail to Alarm on Ventilator Disconnect

    Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.

    Product
    IntelliVue Patient Monitor MX400. Model Number: 866060
    Category
    Medical Device
    Distribution
    2 states
  • 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 (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 (Devices)·Z-1079-2025·2025-02-12

    Philips Allura patient tables recall due to finger entrapment risk

    Philips recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.

    Product
    Allura Xper FD10C System Code: (1) 722001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0485-2025·2025-02-12

    Apple-Filled Paczki from FGF, LLC recalled for potential Listeria contamination

    FGF, LLC is recalling apple-filled paczki sold nationwide due to potential contamination with Listeria monocytogenes. Affected units were produced on or before December 13, 2024.

    Product
    item 8201817 APPLE FILLED PACZKI 66x4 OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2025·2025-02-12

    Philips AlluraXper Patient Tables Pose Finger Entrapment Risk

    Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion fluoroscopy systems. Manual repositioning can trap fingers between the tabletop and rails, risking injury to operators and service personnel.

    Product
    AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
    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 (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-0505-2025·2025-02-12

    FGF Twist Donuts Recalled Due to Listeria Contamination Risk

    FGF's Twist Donuts are being recalled nationwide in the US and Canada due to potential Listeria monocytogenes contamination. The recall affects approximately 2 million cases produced on or before December 13, 2024.

    Product
    item 8201868 GEN TWIST DONUT ZGT PFD 84x1.75 OZ, NET WT 12.93 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2025·2025-02-12

    Philips Allura and Azurion Patient Tables Recall Due to Finger Entrapment Risk

    Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel are at risk of finger injury.

    Product
    AlluraXperFD20/10 System Code: (1) 722029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2025·2025-02-12

    Belmont Medical 3-Spike Disposable Set May Leak During Use

    The Belmont Medical 3-Spike Disposable Set may leak during priming due to a crack in its female quick connector, potentially delaying warmed infusions in hospital settings.

    Product
    Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2025·2025-02-12

    Philips Azurion and Allura Patient Table Finger Entrapment Risk

    Philips Azurion 7 M20 and Allura patient tables pose a finger entrapment risk during manual repositioning. Fingers can get caught between the tabletop and guiding rails, potentially causing finger injury to operators and service personnel.

    Product
    Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2025·2025-02-12

    Philips AD7 and AD7X patient tables recalled due to finger entrapment risk

    Philips has recalled the AD7 and AD7X patient tables used in medical imaging systems because fingers can become entrapped between the tabletop and guiding rails during manual repositioning, potentially causing injury.

    Product
    Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2025·2025-02-12

    Philips recalls AlluraXper FD20 patient tables due to finger entrapment hazard

    Philips is recalling AlluraXper FD20 patient tables due to a finger entrapment hazard. During manual repositioning, fingers can get trapped between the tabletop and rails, risking injury to operators and service personnel.

    Product
    AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0476-2025·2025-02-12

    FGF LLC Persian Donut Recalled for Potential Listeria Contamination

    FGF LLC is recalling Persian Donut item 8201808 nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard it or return it to the retailer.

    Product
    item 8201808 PERSIAN DONUT 78x2.25 OZ, NET WT 9.87 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2025·2025-02-12

    Philips Azurion 5 M20 Patient Tables Recalled for Finger Entrapment Hazard

    Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.

    Product
    Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0218-2025·2025-02-12

    Prescription injection recalled for failed stability test results

    Teva Pharmaceuticals is recalling Granix injection due to failed stability test results showing one peptide did not meet specification limits.

    Product
    GRANIX — GRANIX (TBO-FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0504-2025·2025-02-12

    Just Baked Pumpkin Cake Munchkins recalled for potential Listeria contamination

    FGF, LLC is recalling Just Baked Pumpkin Cake Munchkins nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    item 8201867 JUST BAKED PUMPKIN CAKE MUNCHKINS 440x0.47 OZ, NET WT 12.93 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 (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 (Food)·F-0525-2025·2025-02-12

    Donuts Recalled for Potential Listeria Monocytogenes Contamination

    FGF LLC is recalling egg-shaped donuts nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases were distributed in the US and Canada.

    Product
    item 8201926 FBALL/EGG SHPD DONUT PFD 78 X 2OZ, NET WT 8.78 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2025·2025-02-12

    Patient Monitor May Fail to Alert When Ventilator Disconnects

    Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.

    Product
    IntelliVue Patient Monitor MX450. Model Number: 866062
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0458-2025·2025-02-12

    Monkey Spit BBQ Sauce recalled due to undeclared soy allergen

    Monkey Spit 'Swamp Mop' BBQ Sauce is being recalled because it contains an undeclared soy allergen in a sub-ingredient. The product was distributed through local markets and online sales nationwide.

    Product
    Monkey Spit "Swamp Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Monkey Spit, LLC, Tepusquet Cyn Santa Maria, CA 93454; Manufactured by Smith House MFG. 146-A S. Thompson Ave. Nipomo, CA 93444 (805) 619.7959 UPC#8 54540 00230 3
    Category
    Food
    Distribution
    Distributed nationwide