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.

35526–35550 of 50504

  • HighFDA (Drugs)·D-0956-2016·2016-06-15

    Novo Nordisk Recalls Norditropin Pens Due to Delivery System Defect

    Novo Nordisk is recalling 723 Norditropin FlexPro pens due to a potential assembly fault that may cause the pen to block during the air shot step.

    Product
    NORDITROPIN — NORDITROPIN (SOMATROPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1017-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 2 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 2 vials because FDA inspections found violations that may affect sterility.

    Product
    TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1716-2016·2016-06-15

    Philips Healthcare Ingenuity Core CT System Software Defect Recall

    Philips Healthcare is recalling Ingenuity Core CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1715-2016·2016-06-15

    Philips Brilliance iCT SP CT System Recalled for Software Defects

    Philips Healthcare is recalling Brilliance iCT SP CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1914-2016·2016-06-15

    Ortho VITROS 5600 System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0994-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls M.l.C. Vials Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling M.l.C. 25mg/50mg/25mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1430-2016·2016-06-15

    7-Eleven Sugar Cookie Recalled for Undeclared Peanut Allergen

    Bakery Express is recalling 7-Eleven Fresh To Go Sugar Cookies made with M&M Chocolate Candy because they contain an undeclared peanut allergen.

    Product
    7-Eleven Fresh To Go Sugar Cookie made with M&M (R) Chocolate Candy Net Wt 4.0 oz (114g). Manufactured by Bakery Express in Orlando, FL.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1913-2016·2016-06-15

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software timing anomaly that may cause the device to aspirate or dispense into unintended samples, potentially leading to erroneous or contaminated results.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V432000·2016-06-14

    KZRV Recalls 2016-2017 Spree Travel Trailers Due to Fire Risk

    KZRV is recalling 2016-2017 Spree travel trailers because incorrectly installed refrigerator vents may cause overheating and increase the risk of fire.

    Product
    KZRV — KZRV SPREE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V434000·2016-06-14

    Micro Bird Recalls 2015-2016 Transit Buses for Window Shattering Risk

    Micro Bird is recalling 79 model year 2015-2016 transit buses because water accumulation in window frames can cause glass to shatter in freezing conditions.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS, CT-SERIES, MB II TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E056000·2016-06-13

    Wilson Manifolds Recalls Peter Paul Nitrous Solenoid Valves

    Wilson Manifolds is recalling specific Peter Paul 22X01031GM 12/DC solenoid valves due to improper welding that may cause the piston to eject under pressure.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16194·2016-06-10

    Auldey Toys Recalls Sky Rover Toys Due to Fire Hazard

    Auldey Toys is recalling Sky Rover toys because the included yellow USB charging cords can overheat, posing fire and burn hazards.

    Product
    Sky Rover toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V422000·2016-06-10

    GM Recalls 2013-2016 Chevrolet Vehicles for Missing Seatbelt Warning Chime

    General Motors is recalling specific Chevrolet Spark, Sonic, and Trax vehicles because the radio software may fail to provide audible seatbelt or key-in-ignition warnings.

    Product
    CHEVROLET — CHEVROLET SPARK, SONIC, TRAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E054000·2016-06-09

    Ontario Recalls EVOS Full Face Modular Helmets for Safety Standard Failures

    1888653 Ontario Inc. is recalling specific EVOS Full Face Modular Helmets that may not adequately protect the wearer's head in a crash and lack required safety labeling.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V419000·2016-06-09

    Forest River Recalls 2017 Georgetown Motorhomes Due to Overloading Risk

    Forest River is recalling 2017 Georgetown motorhomes because extra seat belts allow more passengers than the vehicle's weight rating supports, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V416000·2016-06-09

    Daimler Trucks Recalls 2017 Freightliner and Western Star Models for Engine Stall Risk

    Daimler Trucks is recalling specific 2017 Freightliner, Western Star, and FCCC trucks because an engine control module defect may cause the engine to stall without restarting, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR, FCCC CASCADIA, 122SD, 4900, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16191·2016-06-09

    Rhino Metals Recalls Bighorn Handgun Safes Due to Security Flaw

    Rhino Metals is recalling Bighorn P-20 handgun security safes because they can be opened without a combination, posing a serious risk of injury to children and others.

    Product
    Bighorn handgun security safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide