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Recalls from the FDA, USDA FSIS, CPSC and NHTSA, newest first.
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19 recalls

Amneal Pharmaceuticals Estradiol Gel

Estradiol Gel packets may be empty or partially full.

Moderate risk, FDA, Packaging defect

Pipeline Flex Embolization Device with Shield Technology

The Pipeline Flex Embolization Device with Shield Technology has incorrect label dimensions, being 2.50 mm instead of 3.00 mm.

Moderate risk, FDA, Labeling error

Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits

Labeling was updated to warn against using intrapulmonary percussive ventilation with volatile anesthetic delivery systems.

Moderate risk, FDA, Labeling error

Central California Blood Center Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Pathogen Reduced Cryoprecipitated Fibrinogen Complex and Red Blood Cells were collected from a donor not re-entered after positive Chagas testing.

Moderate risk, FDA, Blood donor screening

Cummins L9 Diesel Engines

Cummins L9 diesel engines can leak fuel and stall, increasing fire and crash risks.

NHTSA, Fuel system defect

Mack Anthem AN and Pioneer PR Trucks

Mack Anthem and Pioneer vehicles have inaccurate axle load calculations that can reduce braking performance, increasing crash risk.

NHTSA, Brake defect

Volvo Trucks VNL and VNR Trucks

Volvo VNL and VNR vehicles have inaccurate axle load calculations that may reduce braking performance, increasing crash risk.

NHTSA, Brake defect

American National Red Cross Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced were misbranded and distributed.

Moderate risk, FDA, Mislabeled product

Department of Defense - Army Blood Components

Department of Defense - Army Blood Components, for which arm preparation may have been performed incorrectly, were distributed.

Moderate risk, FDA

Oklahoma Lions Eye Bank Cornea

Corneas were distributed from a donor who was not free from risk factors for infection.

Moderate risk, FDA, Blood donor screening

Eversight Cornea

Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.

Moderate risk, FDA, Blood donor screening

American National Red Cross Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced were misbranded when distributed.

Moderate risk, FDA, Mislabeled product

Versiti Illinois Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had a platelet count higher than acceptable.

Moderate risk, FDA, Quality testing problem

27 recalls

Sempio Korean Ginseng Chicken Stew Classic and Rich

Sempio Korean Ginseng chicken stew products were imported without the benefit of import reinspection.

High risk, FSIS, Import violation

Fontanini Pork Sausage Links

Raw, frozen pork sausage links may contain clear, hard plastic, which can cause injury.

High risk, FSIS, Foreign object

Ajanta Pharma Ranolazine Extended-Release Tablets

Ranolazine Extended-Release Tablets fail dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Philips MRI Scanners and Upgrade Kits

Ingenia Blue Seal SE and Blue Seal XE export incorrect diffusion data when using Enhanced MR Dicom format.

Moderate risk, FDA, Software defect

NOxBOXi Nitric Oxide Delivery System

The NOxBOXi Nitric Oxide Delivery System may have irregular oxygen readings due to a manufacturing issue.

Moderate risk, FDA, Manufacturing problem

Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Moderate risk, FDA, Sterility problem

Cardinal Health 200 Presource Packs Containing Stryker StrykeFlow PS and AHTO Tube Sets

The tube sets may leak fluid during use, potentially causing a slip and fall.

Moderate risk, FDA, Device defect

American Contract Systems BD Urinary Catheter Trays

Medical convenience kits with BD CliniClean Pericare Wipes may contain contaminated wipes causing skin irritation or infection risk.

Moderate risk, FDA, Contamination

American Nitrile Blue Nitrile Patient Examination Gloves

Blue Nitrile Patient examination gloves may have tears, missing fingers, and debris, which can expose people to infectious pathogens or chemical agents.

Moderate risk, FDA, Contamination

United Imaging Computed Tomography and Positron Emission Tomography Systems

The systems have a software problem when Split or Local function is enabled and multiple RIS exams are merged into a single study.

Moderate risk, FDA, Software defect

Volcano Philips IntraSight Plus

The Philips IntraSight Plus may associate image data with another patient's record, potentially causing incorrect diagnosis or treatment.

Moderate risk, FDA, Software defect

Heraeus PALACOS Bone Cement Mixing and Application Systems

Palacos R pro bone cement has a potential for monomer liquid leakage.

Moderate risk, FDA, Device defect

EnCor EnCompass Breast Biopsy and Tissue Removal System Console

The breast biopsy system may experience errors that interrupt or prolong the procedure.

Moderate risk, FDA, Device defect

Merit Medical Embosphere Microspheres

Embosphere syringes may have holes in packaging that could affect the sterile barrier and lead to infection.

Moderate risk, FDA, Sterility problem

McKesson, Alere, Fisher Scientific, and Henry Schein hCG Tests

HCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Moderate risk, FDA, Device defect

ATC RM900 and RM700 Trailers

RM900 and RM700 trailers have coupler mounting bolts that may loosen, separating the coupler and causing loss of control.

NHTSA, Trailer hitch defect

HeartSine Samaritan PAD Public Access Defibrillators

HeartSine samaritan PAD defibrillators were distributed without the required Maintenance Supplement.

Low risk, FDA, Device defect

Saving Sight Cornea

Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.

Low risk, FDA, Blood donor screening

VisionGift Cornea

The cornea was distributed without ensuring the donor was free from risk factors for and clinical evidence of relevant communicable disease agents and diseases.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications and was distributed.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications and was distributed.

Moderate risk, FDA, Quality testing problem

28 recalls

Deano's Pasta Pear and Pecorino Triangoli Ravioli

Deano's Pasta Pear and Pecorino Triangoli Ravioli may contain undeclared lobster, posing a risk of serious allergic reaction.

High risk, FDA, Undeclared shellfish

Lior Brand Cinnamon Ground Seasoning

Lior brand Cinnamon Ground Seasoning contains elevated levels of lead, which can cause permanent damage to the central nervous system in children.

Moderate risk, FDA, Chemical contamination

Style Homeware Emerspring Mattresses

Emerspring Mattresses violate flammability standards, posing a fire hazard that can cause serious injury or death.

CPSC, Fire hazard

5Color Children's Bike Helmet and Pads Sets

The 5Color children's bicycle helmet and pads sets fail to meet safety standards and may not protect against head injury.

CPSC, Impact hazard

WinxMatrs Mattresses

WinxMatrs mattresses fail flammability standards, posing a fire risk.

CPSC, Fire hazard

Kesyup-Branded Mattresses

Kesyup mattresses violate flammability standards, posing a fire risk.

CPSC, Fire hazard

NEWDERY Power Banks

NEWDERY power banks can explode or ignite, posing fire and burn hazards.

CPSC, Fire hazard

Love To Dream Portable Sleep Machines with Night Light

The portable sleep machines can overheat if the charger is not compatible, posing fire and burn hazards.

CPSC, Fire hazard

Hyperfuels Methanol and Ethanol Fuel Containers

The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly flame jetting hazard.

CPSC, Fire hazard

ABC Trading Light-Up Glasses, Headbands and Ties

Light-up children's toys contain easily accessible button cell batteries, posing a deadly ingestion hazard to children.

CPSC, Swallowing hazard