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.

28501–28525 of 50488

  • HighNHTSA·18V431000·2018-06-21

    BMW Recalls 2018 X3 Models for Rear Turn Signal Color Defect

    BMW is recalling 2018 X3 xDrive30i and M40i vehicles because rear turn signals may display incorrect colors, potentially confusing other drivers.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1542-2018·2018-06-20

    Manischewitz Dark Chocolate Potato Chips Recalled for Undeclared Allergens

    R.A.B. Food Group LLC is recalling Manischewitz Dark Chocolate covered Potato Chips due to undeclared peanut, tree nut, and milk allergens.

    Product
    Manischewitz Brand, Dark Chocolate covered Potato Chips, 4.25 oz /12 per case, in mylar metalized bag in gable box,
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2157-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 2 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2220-2018·2018-06-20

    Angiodynamics Recalls Xcela Maximal Barrier Nursing Kits Due to Endotoxins

    Angiodynamics Inc. is recalling Xcela 5FDL-55cm Maximal Barrier Nursing Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2206-2018·2018-06-20

    Angiodynamics Recalls TANDEM 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling TANDEM 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2219-2018·2018-06-20

    Angiodynamics Recalls CAN 5F Dual Xcela PICC Kits for Endotoxin Risk

    Angiodynamics Inc. is recalling 27 boxes of CAN 5F Dual Xcela PICC kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2181-2018·2018-06-20

    Siemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Gentamicin Flex reagent cartridges because they may produce inaccurate test results at the low end of the measurement range.

    Product
    Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1563-2018·2018-06-20

    H-E-B Rainbow Sherbet Recalled for Potential Broken Metal Pieces

    H-E-B is recalling Rainbow Sherbet quarts because they may contain broken metal pieces. The product was distributed in Texas and Mexico.

    Product
    HEB Creamy Creations Rainbow Sherbet quart
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2145-2018·2018-06-20

    Sun Med STAT-Check Manual Resuscitator Recalled for Port Detachment Risk

    Sun Med, LLC is recalling STAT-Check Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.

    Product
    STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1557-2018·2018-06-20

    Hill Country Fare Vanilla Ice Cream Recalled for Metal Pieces

    H-E-B is recalling Hill Country Fare Vanilla ice cream in 4.5-quart containers because the product may contain broken metal pieces.

    Product
    Hill Country Fare Vanilla 4.5 quarts
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2178-2018·2018-06-20

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 10 units of Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2182-2018·2018-06-20

    Siemens Gentamicin Reagent Cartridge Recall Due to Low-End Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Gentamicin Flex reagent cartridges because they may produce inaccurate results at low concentrations.

    Product
    Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2018·2018-06-20

    Roche cobas e 801 Immunoassay Analyzer Recalled for Plunger Defect

    Roche Diagnostics is recalling 35 cobas e 801 immunoassay analyzers because a tilted syringe plunger may crack, leading to impaired syringe function.

    Product
    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1564-2018·2018-06-20

    H-E-B Strawberry Sherbet Recalled for Potential Broken Metal Pieces

    H-E-B is recalling specific quart containers of Creamy Creations Strawberry & Cream Swirl Sherbet because they may contain broken metal pieces.

    Product
    HEB Creamy Creations Strawberry & Cream Swirl Sherbet quart
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2060-2018·2018-06-20

    Shimadzu Sonialvision Safire II X-ray System Recalled for Irradiation Display Error

    Shimadzu Medical Systems is recalling 17 Sonialvision Safire II angiographic x-ray systems because the irradiation time and integral dose displays may reset to zero during serial radiography.

    Product
    Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2018·2018-06-20

    Angiodynamics Recalls RS Tandem 5F DL Bioflo Pasv Catheters

    Angiodynamics Inc. is recalling RS Tandem 5F DL Bioflo Pasv catheters because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
    Category
    Medical Device
    Distribution
    34 states
  • HighCPSC·18179·2018-06-20

    Werner Recalls Telescoping Aluminum Ladders Due to Fall Hazard

    Werner is recalling about 78,000 telescoping aluminum ladders because they can break while in use, posing a fall hazard.

    Product
    Multi-Purpose Telescoping Aluminum Ladders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2018·2018-06-20

    Angiodynamics Recalls RS TANDEM 5F DL BIOFLO PASV Catheters

    Angiodynamics Inc. is recalling 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
    Category
    Medical Device
    Distribution
    34 states