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.

35801–35825 of 50504

  • HighUSDA FSIS·042-2016·2016-05-19

    Conagra Recalls Two Beef Products Due To Undeclared Fish Allergen

    Conagra Foods is recalling two frozen beef products because they may contain undeclared fish (anchovies) from Worcestershire sauce.

    Product
    ConAgra Brands, Inc. — Conagra Foods Packaged Foods, LLC Recalls Two Beef Products Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V323000·2016-05-19

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Coolant Leak Risk

    Daimler Trucks North America is recalling 2014-2017 Thomas Built Buses Saf-T-Liner HDX school buses because a rubber coolant elbow may fail, leaking hot coolant inside the bus.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16164·2016-05-19

    Black Diamond Recalls Index Climbing Ascenders Due to Fall Hazard

    Black Diamond is recalling Index Ascenders because a rivet may release, causing the device to detach from the rope and posing a risk of injury or death.

    Product
    Black Diamond Index Ascenders for climbing
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16168·2016-05-19

    Black Diamond Recalls Camalot Climbing Devices Due to Fall Hazard

    Black Diamond is recalling approximately 45,500 Camalot and Camalot Ultralight climbing devices because they can come apart during use, posing a fall hazard.

    Product
    Black Diamond Camalot climbing devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1325-2016·2016-05-18

    CVS Gold Emblem Organic Spiced Herbal Tea Recalled for Salmonella

    CVS Health is recalling Gold Emblem Abound Organic Spiced Herbal Tea because the product contains Salmonella. Consumers should stop using the product.

    Product
    Gold Emblem Abound Organic Spiced Herbal Tea, 20 TEA BAGS, NET WT 1.41 OZ (40g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1624-2016·2016-05-18

    Hamilton G5 Ventilator Recalled for Suctioning Maneuver Software Defect

    Hamilton Medical is recalling 1,115 Hamilton G5 ventilators because the ventilation pattern may not continue as expected after a suctioning maneuver.

    Product
    Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·16V315000·2016-05-18

    Lakota Luxe Trailers Recalled for Microwave Fire Risk

    Lakota is recalling 2014 Luxe trailers because the built-in microwave may start on its own, posing a fire hazard.

    Product
    LAKOTA — LAKOTA LUXE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2016·2016-05-18

    C.R. Bard Recalls Arctic Sun Temperature Management Systems

    C.R. Bard is recalling 2,613 Arctic Sun Temperature Management Systems because electronic components may cause the internal battery to drain prematurely, rendering the device unresponsive.

    Product
    Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1613-2016·2016-05-18

    Novarad NovaPACS Diagnostic Viewer Recalled for Incorrect SUV Calculations

    Novarad Corporation is recalling specific versions of NovaPACS Diagnostic Viewer because the PET/CT fusion tool calculates incorrect SUV values.

    Product
    NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2016·2016-05-18

    Recall of Given Imaging Bravo pH Capsule Delivery Devices

    Covidien LLC is recalling Bravo pH capsule delivery devices due to a potential risk of allergic reactions in patients with nickel sensitivity.

    Product
    Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16163·2016-05-18

    phil&teds Recalls Dash Strollers Due to Hinge Pinch Hazard

    phil&teds is recalling about 630 Dash v5 strollers in the U.S. because the folding hinge can become damaged, posing a pinch hazard to consumers.

    Product
    phil&teds dash strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2016·2016-05-18

    FDA Recalls Given Imaging Bravo pH Capsule Delivery Device

    FDA is recalling the Given Imaging Bravo pH capsule delivery device due to a potential allergic reaction risk for patients with nickel sensitivity.

    Product
    Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2016·2016-05-18

    Stanmore Distal Femoral Replacement Recalled for Incorrect Component

    Stanmore Implants Worldwide Ltd. is recalling one custom-made distal femoral replacement implant due to the use of an incorrect component during manufacturing.

    Product
    Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1665-2016·2016-05-18

    Siemens Dimension Vista Triglyceride Assay Recalled for Interference

    Siemens is recalling Dimension Vista Triglyceride assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Triglycerides (TRIG)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2016·2016-05-18

    Applied Medical Direct Drive Clip Applier Recalled for Inconsistent Application

    Applied Medical Resources Corp is recalling Direct Drive Clip Applier CA090 units due to inconsistent clip application that may lead to unoccluded vessels.

    Product
    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1654-2016·2016-05-18

    Siemens ADVIA Chemistry Enzymatic Creatinine 2 Recalled for Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine 2 reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY ENZYMATIC CREATININE_2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2016·2016-05-18

    Siemens Recalls Direct HDL Cholesterol Assay Due to Interference

    Siemens Healthcare Diagnostics is recalling the Advia Chemistry Assay: Direct HDL Cholesterol due to potential falsely depressed results caused by NAC or Metamizole interference.

    Product
    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16E047000·2016-05-18

    Cummins Recalls ISX12 and ISX15 Engines for Electrical Module Defect

    Cummins is recalling specific ISX12 and ISX15 engines due to a potential Engine Control Module short circuit that may cause the engine to stall without warning.

    Product
    ELECTRICAL SYSTEM:IGNITION:MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1322-2016·2016-05-18

    Salsa Dianne Recalls Classic Pesto Sauce for Undeclared Milk Allergen

    Salsa Dianne is recalling Classic Pesto Sauce (with a twist) because the label declares Parmesan cheese but fails to list milk as an ingredient.

    Product
    Classic Pesto Sauce (with a twist), net wt. 4 oz. (113 g). Product is packaged in a round Styrofoam containers with translucent plastic lid. The UPC is 8 20103 77214 3. The product is labeled in parts: "***Classic Pesto (with a twist)***INGREDIENTS: Olive Oil, Brazil nuts…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1660-2016·2016-05-18

    Siemens Dimension Enzymatic Creatinine Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Assays: ENZYMATIC CREATININE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1331-2016·2016-05-18

    Nuwati Herbals Tea Recalled for Undeclared Soy Allergen

    Nuwati Herbals Inc. is recalling SeeLessO'Me Diet and Weight Management Tea because it contains undeclared soy. Consumers with soy allergies should not consume the product.

    Product
    Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 oz. The responsible name on the label is Nuwati Herbals Inc., House Springs, MO.
    Category
    Food
    Distribution
    Distributed nationwide