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.

44376–44400 of 50511

  • HighFDA (Food)·F-0752-2013·2012-12-12

    Zingerman's Bakehouse Chocolate Cookies Recalled for Allergen Mislabeling

    Zingerman's Bakehouse is recalling Funky Chunky Chocolate Cookie Jrs. because the labels failed to identify milk and wheat as ingredients.

    Product
    Zingerman's Bakehouse Funky Chunky Chocolate Cookie Jrs. Net wt. 6 ounces
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0786-2013·2012-12-12

    Zingerman's Bakehouse Granola Recalled for Missing Milk Allergen Labeling

    Zingerman's Bakehouse is recalling Mary's Wild Oats Cranberry Almond Granola because the labels failed to identify milk as an ingredient source.

    Product
    Zingerman's Bakehouse Mary's Wild Oats Cranberry Almond Granola 1 lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0466-2013·2012-12-12

    Philips and Neusoft Recall CT Scanners Due to Detaching Patient Table

    Philips and Neusoft are recalling 45 CT scanners because the patient table top can detach from the carrier, posing a risk of injury.

    Product
    NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2013·2012-12-12

    Invivo Expression MRI Patient Monitoring System Recalled for Detached Caster Risk

    Invivo Corporation is recalling the Expression MRI Patient Monitoring System because a caster may detach during transport, causing the cart to fall.

    Product
    Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2013·2012-12-12

    OmniGuide BP-ROBOTIC Fiber Recalled Due to Glue Joint Failure

    OmniGuide, Inc. is recalling 45 units of BP-ROBOTIC single-use fibers because a glue joint failure may cause the device to shift and fall into the patient.

    Product
    OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0789-2013·2012-12-12

    Zingerman's Bakehouse Coffeecake Recalled for Allergen Mislabeling

    Zingerman's Bakehouse is recalling Nueske's Bacon Apple Coffeecake because labels failed to identify milk, wheat, and soy allergens.

    Product
    Zingerman's Bakehouse Nueske's Bacon Apple Coffeecake Net wt. 1.25 lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0459-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0461-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.

    Product
    24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0460-2013·2012-12-12

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Plastic Flash

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0456-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Food)·F-0793-2013·2012-12-12

    Zingerman's Bakehouse Brownies Recalled for Allergen Mislabeling

    Zingerman's Bakehouse is recalling brownies because labels failed to identify milk, wheat, and soy allergens.

    Product
    Zingerman's Bakehouse Brownies -Magic & Black Magic (variety pack) Net wt. 1.2 lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0473-2013·2012-12-12

    Roche Recalls 78 Cobas 8000 Analyzers Due to Reagent Pipetting Defect

    Roche Diagnostics is recalling 78 Cobas 8000 Modular Analyzers because a probe positioning mismatch can cause insufficient reagent pipetting, potentially affecting test results.

    Product
    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide