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.

33776–33800 of 50502

  • HighFDA (Devices)·Z-0655-2017·2016-11-30

    Hologic Recalls SURESOUND22 Uterine Sounds Due to Sterile Barrier Breach

    Hologic is recalling SURESOUND22 uterine sound multipacks because a breach in the sterile barrier compromises product sterility.

    Product
    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0530-2017·2016-11-30

    EN-R-G Foods Recalls Protein Chews Due to Nausea and Vomiting Complaints

    EN-R-G Foods is recalling Cherry Lime, Raspberry, and Juneberry Protein Chews due to consumer complaints of nausea and vomiting after consumption.

    Product
    Protein Chews Raspberry,1.8oz, film package, 12 packets per box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2017·2016-11-30

    Merit Medical Recalls Manifold Kits Due to Compromised Sterile Barrier

    Merit Medical Systems is recalling 40 Manifold Kits (Catalog No. K09-11867AP) because the sterile barrier is compromised, posing a risk of infection.

    Product
    Manifold Kit. Catalog Number K09-11867AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0520-2017·2016-11-30

    CSM Bakery Cream Cake Mix Recalled for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling 38260 Cream Cake Mix because it contains undeclared peanut protein. The product was distributed in 19 states and two territories.

    Product
    38260 Cream Cake Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0634-2017·2016-11-30

    Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise

    Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.

    Product
    Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2017·2016-11-30

    DePuy ACTIS Flex Reamers Recalled Due to Breakage Risk

    DePuy Orthopaedics is voluntarily recalling ACTIS Flex Reamers because the instruments may break and leave pieces in patients.

    Product
    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0622-2017·2016-11-30

    Toshiba Aquilion Prime CT System Recalled for Cooling Oil Leak Risk

    Toshiba American Medical Systems is recalling Aquilion Prime CT systems because cooling oil in the x-ray tube heat exchanger may leak during operation.

    Product
    Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V861000·2016-11-30

    Cummins Recalls 2015-2016 Generator Sets Due to Door Hinge Failure Risk

    Cummins is recalling 164 model year 2015-2016 generator sets because door hinges may fail, causing doors to detach and create road hazards.

    Product
    CUMMINS POWER GENERATION — CUMMINS POWER GENERATION GENERATOR SET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2017·2016-11-30

    Philips CT Scanner Recall Due to Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0506-2017·2016-11-30

    CSM Bakery Products Recalls Donut Mix for Undeclared Peanut Protein

    CSM Bakery Products NA is recalling BM Westco Sup-R-Roll Donut Mix because it contains undeclared peanut protein. The product was distributed in multiple US states and territories.

    Product
    BM Westco Sup-R-Roll Donut Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0516-2017·2016-11-30

    CSM Bakery Recalls ZT Banana Bread Mix for Undeclared Peanut Protein

    CSM Bakery Products NA is recalling ZT Banana Bread Mix because it contains undeclared peanut protein. The product was distributed in 19 states, Puerto Rico, and Guam.

    Product
    ZT Banana Bread Mix, 13.5#
    Category
    Food
    Distribution
    19 states
  • HighNHTSA·16V863000·2016-11-30

    LGS Recalls 2017 Pace, Cargo Express, and Look Cargo Trailers

    LGS Industries is recalling 2017 Pace, Cargo Express, and Look cargo trailers because a defective weld could cause the ramp door bracket to detach, creating a crushing hazard.

    Product
    PACE — PACE, CARGO EXPRESS, LOOK CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2017·2016-11-30

    Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier

    Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.

    Product
    Waste Management Kit. Catalog Number K10-04381AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0511-2017·2016-11-30

    CSM Bakery Products Recalls Bread Mix for Undeclared Peanut Protein

    CSM Bakery Products NA is recalling BM Westco New Horizon Yrd Mix, 50# due to undeclared peanut protein. The product was distributed across multiple states and territories.

    Product
    BM Westco New Horizon Yrd Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0652-2017·2016-11-30

    Siemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery

    Siemens is recalling Dimension Vista Chemistry 1 Calibrators (lots 5GM081 and 5GM082) because they may cause discrepant low calcium recovery in quality control and patient samples.

    Product
    Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0524-2017·2016-11-30

    CSM Bakery Recalls Choco Cream Cake Base Due to Undeclared Peanut

    CSM Bakery Products NA is recalling Brill Choco Cream Cake Base because it contains undeclared peanut protein. The product was distributed across 19 states, Puerto Rico, and Guam.

    Product
    Brill Choco Cream Cake Base, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0651-2017·2016-11-30

    Bausch + Lomb Recalls PeroxiClear Peroxide Solution for Excess Residuals

    Bausch + Lomb is recalling PeroxiClear Peroxide Solution because the product was found to contain excess residual levels of hydrogen peroxide.

    Product
    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting…
    Category
    Medical Device
    Distribution
    Distributed nationwide