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.

28251–28275 of 50488

  • HighFDA (Devices)·Z-2547-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Cell Culture Medium Due to Seal Defect

    Life Technologies is recalling 70 units of Gibco DMEM cell culture medium because compromised fill port seals may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2536-2018·2018-08-01

    Bard Medical Recalls Arctic Sun Temperature Management Systems Due to Wiring Defect

    Bard Medical Division is recalling 5,608 Arctic Sun 5000 Temperature Management Systems because an improper wiring connection may cause overheating and component failure.

    Product
    Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of…
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2554-2018·2018-08-01

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to erroneous beam profile parameters that may cause incorrect dose calculations in large or off-axis fields.

    Product
    RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2018·2018-08-01

    Medela Invia Motion Negative Pressure Wound Therapy System Recalled for Battery Error

    Medela Inc is recalling 778 units of the Invia Motion Negative Pressure Wound Therapy System because the device may display a battery missing error.

    Product
    Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2018·2018-08-01

    Leica M320 Microscope Systems Recalled for Gas Spring Bracket Failure

    Leica Microsystems is recalling 8,564 M320 Microscope Systems because screws holding the gas spring bracket may fail, causing the optics carrier to drop.

    Product
    Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V510000·2018-07-31

    Heartland Sundance XLT TT Recalled for Incorrect Tire Load Rating

    Heartland is recalling 2018 Sundance XLT TT trailers equipped with incorrect Load Range C tires. Owners should contact dealers to replace them with correct Load Range D tires.

    Product
    HEARTLAND — HEARTLAND SUNDANCE XLT TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V504000·2018-07-31

    Cummins Recalls 2015-2018 Generator Sets Due to Wiring Defect

    Cummins is recalling 2015-2018 generator sets because incorrect wiring may prevent the remote emergency stop from functioning, increasing injury risk.

    Product
    CUMMINS POWER GENERATION — CUMMINS POWER GENERATION GENERATOR SET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-07302018-1·2018-07-30

    Caito Foods Recalls Beef, Pork, and Poultry Salad and Wrap Products

    Caito Foods LLC is recalling beef, pork, and poultry salad and wrap products due to concerns about Cyclospora contamination. The products were distributed nationwide.

    Product
    Caito Foods, LLC — FSIS Issues Public Health Alert for Beef, Pork and Poultry Salad and Wrap Products due to Concerns about Contamination with Cyclospora
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V496000·2018-07-27

    Hyundai Recalls 2018 Genesis G80 for Passenger Air Bag Sensor Defect

    Hyundai is recalling 2018 Genesis G80 vehicles because the occupant classification system may fail to deactivate the front passenger air bag, increasing injury risk for children.

    Product
    GENESIS — GENESIS G80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18195·2018-07-27

    Hirsch Gift Recalls CloudCharge Wireless Charging Pads Due to Burn Hazard

    Hirsch Gift is recalling about 21,000 CloudCharge Qi Wireless Charging Pads because they can overheat and cause burns. Consumers should stop using the pads and contact the company for a free replacement.

    Product
    CloudCharge Qi Wireless Charging Pads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18E062000·2018-07-27

    PTL Recalls Recreational Vehicle Doors Due to Latch Adjustment Defect

    PTL Engineering is recalling 3000 and 7000 Series RV entry doors because the latch rod may be improperly adjusted, allowing the door to open while the vehicle is moving.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V490000·2018-07-26

    Forest River Recalls 2019 Prime Time Crusader Trailers for Incorrect Placard

    Forest River is recalling 2019 Prime Time Crusader fifth-wheel trailers because the Federal Placard lists an incorrect axle weight capacity, which could lead to axle overload and loss of control.

    Product
    PRIME TIME — PRIME TIME CRUSADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18193·2018-07-26

    Trek Recalls Bontrager Line Pro Bicycle Pedals Due to Fall Hazard

    Trek is recalling Bontrager Line Pro flat bicycle pedals because the spindle can break, posing a fall hazard. No injuries have been reported.

    Product
    Bontrager Line Pro flat bicycle pedals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18194·2018-07-26

    Jimmy Hack Golf Recalls Orange Whip Swing Trainers Due to Injury Hazard

    Jimmy Hack Golf is recalling Orange Whip swing trainers because the weighted orange ball can detach during use, posing an injury risk to users and bystanders.

    Product
    Orange Whip golf swing trainers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2501-2018·2018-07-25

    Medtronic Recalls Visualase Cooled Laser Applicator Systems Due to Calibration Issues

    Medtronic is recalling 1,283 Visualase Cooled Laser Applicator Systems because calibration errors may cause low laser energy output or fiber burnout.

    Product
    Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2018·2018-07-25

    Medtronic Vectris MRI Lead Kit Recalled for Needle Defect

    Medtronic is voluntarily recalling Vectris Sure Scan MRI Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.

    Product
    Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0942-2018·2018-07-25

    Avella Recalls Ropivacaine Infusion Bags Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 20 bags of 0.2% Ropivacaine infusion cassettes due to potential leakage that compromises sterility.

    Product
    0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0934-2018·2018-07-25

    Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 240 bags of Heparin 25,000 Units in 5% Dextrose due to potential bag leakage and lack of sterility assurance.

    Product
    HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

    Product
    Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2466-2018·2018-07-25

    Ethicon Recalls Pronova Suture Due to Packaging Perforation Risk

    Ethicon is recalling 516 units of Pronova Suture Blue because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PRONOVA SUTURE BLUE 122CM M1.5, D10189
    Category
    Medical Device
    Distribution
    25 states