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.

44051–44075 of 50511

  • HighFDA (Devices)·Z-0820-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they fail to transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they do not transmit 'HI' or 'LO' blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2013·2013-02-20

    Terumo CDI 101 Hematocrit Monitor Recalled for Inaccurate Readings

    Terumo is recalling 622 CDI 101 Hematocrit/Oxygen Saturation Monitoring Systems because software errors cause inaccurate readings of blood and oxygen levels.

    Product
    Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0975-2013·2013-02-20

    Suadel Recalls Yellow Dough Shells for Undeclared Allergens and Dye

    Suadel Food Products is recalling Estrella yellow dough shells in Puerto Rico due to undeclared Yellow #6 and soy.

    Product
    "Estrella Food Products, Inc***Plantillas Para Pastelillos, tacos, Empanadillas, etc. (Yellow dough shells)***12 units, and 20 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0816-2013·2013-02-20

    Richmar Cloth Electrodes Recalled for Terminal Separation Defect

    NAImco Inc dba Richmar Inc is recalling cloth electrodes where the socket terminal may pull away from the lead wire.

    Product
    Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0798-2013·2013-02-20

    Mindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly

    Mindray is recalling 51 DPM Central Monitoring Systems because a software anomaly may display a step pattern instead of a flat line during asystole.

    Product
    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V051000·2013-02-19

    Hyundai Recalls 2012 Veloster Vehicles Due to Sunroof Glass Defect

    Hyundai is recalling 2012 Veloster vehicles with panoramic sunroofs because the glass assembly may be weakened, posing a risk of breakage while driving.

    Product
    HYUNDAI — HYUNDAI VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E008000·2013-02-15

    Yakima SpareTime Bike Rack Recall Due to Mounting Bolt Failure

    Yakima is recalling SpareTime two-bike rack systems because mounting bolts may break, causing the rack to fall and create a road hazard.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13121·2013-02-14

    Cramer Recalls Folding Step Stools Due to Fall Hazard

    Cramer LLC is recalling Task*It 1-UP folding step stools because they can crack or break, posing a fall hazard to users.

    Product
    Task*It 1-UP folding step stool
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13120·2013-02-13

    MJC Recalls Beamerzzz Stuffed Animals with LED Flashlights Due to Laceration Hazard

    MJC is recalling Beamerzzz stuffed animals with LED flashlights sold at Cabela's because exposed wires pose a laceration hazard. Consumers should remove the toys from children and contact the manufacturer for a replacement.

    Product
    Beamerzzz™ Stuffed Animals with LED Flashlight
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0968-2013·2013-02-13

    Dried Preserved Plum Recalled for Lead Contamination

    Nuera Trading Company is recalling Dried Preserved Plum packages due to lead levels exceeding safety limits found by the California Department of Public Health.

    Product
    Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10 x 4.4 lb packages. Net weight of one case is 44 lbs.. Product information is provided on the case with product name "Dried Preserved Plum"…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0770-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Defects

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity levels below the specified range. The recall includes units manufactured since March 2009 and was expanded in October 2012.

    Product
    Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0965-2013·2013-02-13

    Annie's Homegrown Pizza Recalled for Potential Metal Fragments

    Annie's Homegrown is recalling Rising Crust Four Cheese Pizza due to a faulty screen at the flour mill that may have allowed metal fragments into the product.

    Product
    Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package. Product UPC: 0 13562-20001 6; Case UPC 1 00 13562 20001 3 Annie's, Inc. 1610 5th Street Berkeley, CA 94710
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0966-2013·2013-02-13

    Annie's Homegrown Spinach and Mushroom Pizza Recalled for Metal Fragments

    Annie's Homegrown is recalling specific pizzas due to potential metal fragments from a faulty flour mill screen.

    Product
    Annie's Homegrown Rising Crust Spinach and Mushroom Pizza. Spinach, Portobello and Button mushrooms with a Garlic Parmesan cream sauce.. Certified Organic, 25.0 oz package. Product UPC: 0 13562-20005 4; Case UPC 1 00 13562 20005 1 Annie's, Inc. 1610 5th Street…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0967-2013·2013-02-13

    Annie's Homegrown Four Cheese Pizza Recalled for Potential Metal Fragments

    Annie's Homegrown is recalling Rising Crust Four Cheese Pizza due to a faulty screen at the flour mill that may have allowed metal fragments into the product.

    Product
    Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. 22.5 oz package. Product UPC: 0 13562-20007 8; Case UPC 1 00 13561 20007 5. Annie's, Inc. 1610 5th Street Berkeley, CA 94710
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0772-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects

    Zimmer, Inc. is recalling Trilogy Acetabular Shell Spiked units because some may have porosity levels below the required specification.

    Product
    Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2013·2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling breast biopsy trays because they may contain particulate matter in the included sodium chloride.

    Product
    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect

    Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.

    Product
    Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2013·2013-02-13

    Winco Premier Care Recliners Recalled for Fire Safety Non-Compliance

    Winco Mfg. is recalling 95 Premier Care Recliners because the foam and vinyl chemicals do not consistently meet California's TB 133 fire protection mandate.

    Product
    PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2013·2013-02-13

    Winco Medical Recliners Recalled for Fire Protection Non-Compliance

    Winco Mfg. is recalling 95 medical recliners because their foam and vinyl do not meet California fire safety standards.

    Product
    Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Defect

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity below the specified range. The recall includes 275,952 units distributed worldwide.

    Product
    Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect

    Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.

    Product
    Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide