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

Eversight Illinois Cornea

Cornea, recovered from a donor in which donor eligibility was not adequately determined, was distributed.

Moderate risk, FDA, Blood donor screening

OneLegacy Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

San Antonio Eye Bank Cornea

A mislabeled cornea was distributed.

Moderate risk, FDA, Labeling error

South Dakota Lions Eye Bank Cornea

Corneas were distributed from a donor not adequately tested for communicable diseases.

Low risk, FDA, Quality testing problem

Lions Eye Bank Of Nebraska Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Blood donor screening

Tissue Transplant Technology Bone

Bone products could cause contamination or spread of disease.

Moderate risk, FDA, Contamination

American Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but came from a donor who tested positive.

Moderate risk, FDA, Labeling error

ImpactLife Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

Moderate risk, FDA, Quality testing problem

American National Red Cross Apheresis Platelets and Red Blood Cells

Apheresis Platelets and Red Blood Cells were out of monitored storage for an extended period.

Low risk, FDA, Processing problem

Carter BloodCare Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were leukoreduced by filtration at an unacceptable temperature.

Low risk, FDA, Processing problem

26 recalls

Niwali Tejocote Capsules and Niwali Tejocote Pieces

Niwali Tejocote Capsules and Pieces contain yellow oleander, which can cause severe or fatal health effects.

FDA

United Sugar Producers: Light Brown Sugar and Powdered Sugar

Light brown sugar may contain wheat kernels.

Moderate risk, FDA, Contamination

Sterling Pharmaceutical Services Lubricant Eye Drops and Ointments

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

ARUP Laboratories Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor taking an unlicensed, unapproved, or experimental medication.

Moderate risk, FDA, Blood donor screening

American Red Cross Apheresis Platelets

Apheresis Platelets were distributed without testing for pH or platelet yield.

Moderate risk, FDA, Quality testing problem

Vitalant Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed from a donor with travel history to a malaria endemic area but not assessed for residency.

Moderate risk, FDA, Blood donor screening

ForeSight Elite Tissue Oximetry Cable

The ForeSight Elite Tissue Oximetry Cable has incorrect switching of channels 1 and 2 on the module and flag labels.

Moderate risk, FDA, Labeling error

Forest River Dynamax Grand Sport GT Recreational Vehicles

The engine pre-heat pump may be improperly installed, causing coolant hose failure.

NHTSA, Fuel system defect

Abiomed Impella Controllers

The Automated Impella Controller has defects in firmware and software that can affect pressure signal accuracy and cause unreliable signals.

Moderate risk, FDA, Software defect

CorneaGen Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Iowa Lions Eye Bank Cornea

Corneas were processed using an expired viewing chamber.

Moderate risk, FDA

CorneaGen 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

OneLegacy 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

Rocky Mountain Lions Eye Bank Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Eversight Cornea

Cornea, recovered from a donor in which donor eligibility was not adequately determined, was distributed.

Moderate risk, FDA, Blood donor screening

Precision Ocular Network - Bartlett Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Precision Ocular Network Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

Corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.

Low risk, FDA, Quality testing problem

Department of Defense Navy Whole Blood

Whole Blood tested negative for anti-HTLV but was collected from a donor who previously tested reactive.

Moderate risk, FDA, Blood donor screening

HCSC-Blood Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were exposed to unacceptable storage temperatures.

Low risk, FDA, Processing problem

The Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were incorrectly labeled as irradiated and distributed.

Moderate risk, FDA, Labeling error

Department of Defense Air Force Red Blood Cells

Red Blood Cells were collected from a donor who previously tested repeatedly reactive for HTLV-I antibody.

Moderate risk, FDA, Blood donor screening

Mississippi Blood Services Red Blood Cells, Leukocytes Reduced

Red blood cells were collected from a donor with low hemoglobin or without a hemoglobin check.

Moderate risk, FDA, Blood donor screening

Mississippi Blood Services Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Blood donor screening

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

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

Moderate risk, FDA, Quality testing problem

Eversight Illinois Cornea

Cornea was processed without the proper antibiotic soak.

Moderate risk, FDA, Processing problem

21 recalls

Endo Dexmedetomidine HCl in 0.9% Sodium Chloride Injection

Dexmedetomidine HCL in 0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.

High risk, FDA, Foreign object

Truly AIP All Purpose Flour and Bread Mix, and EAT G.A.N.G.S.T.E.R. Flat Bread Pizza Mix

All purpose flour, bread mix, and flat bread pizza mix contain undeclared wheat gluten.

FDA

Philips Achieva, Ingenia, Intera and MR MRI Systems

A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted.

Moderate risk, FDA, Software defect

Pearle Vision 1 day (Somofilcon A) Contact Lens

Some Pearle Vision 1 day contact lenses have the incorrect power.

Moderate risk, FDA, Device defect

bioMérieux VITEK 2 AST-N461 Test Kit

The Vitek 2 AST-N461 test kit may cause false resistant results due to card pouch damage.

Moderate risk, FDA, Device defect

Medline Convenience Kits Containing Healthmark Instrument Channel Brushes

Medline convenience kits contain brushes with a sharp edge that can cut and infect.

Moderate risk, FDA, Device defect

Philips EPIQ Elite Diagnostic Ultrasound System

The Philips EPIQ Elite ultrasound system has a software issue that can cause inaccurate blood flow measurements and misdiagnosis.

Moderate risk, FDA, Software defect

Elegant Foods Pecorino Toscano D.O.P. Stagionato Cheese Wheels

Pecorino Toscano D.O.P. Stagionato cheese wheels may be contaminated with Listeria from dripping condensation.

Moderate risk, FDA, Listeria

Fresenius Medical Care CombiSet Hemodialysis Blood Tubing Sets

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Moderate risk, FDA, Device defect

Maquet PowerLED 300 Concealed Lighting System

The PowerLED 300 Concealed Lighting System can detach at the junction between the spring arm and suspension arm and fall, causing potential injury.

Moderate risk, FDA, Device defect

SeaSpine Mariner Deformity Extended Polyaxial Head

The spinal device has a thread depth out of design specification.

Moderate risk, FDA, Device defect

HomeFill Oxygen Cylinders

Oxygen cylinders lack required medical gas labeling.

Moderate risk, FDA, Labeling error

CooperSurgical INCA Infant Nasal CPAP Sets

The INCA Infant Nasal CPAP Complete Set may have a loose tubing connection, causing loss of pressure and reduced oxygenation.

High risk, FDA, Device defect

Midmark IQvitals Zone

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Moderate risk, FDA, Device defect