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FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,957 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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13 recalls that day

Endo USA Buprenorphine Hydrochloride Injection

Buprenorphine Hydrochloride Injection can crystallize.

Moderate risk, FDA, Quality problem

Organiccs Absolutely Pure, Type-1 Hydrolyzed Collagen Peptides

Organiccs Absolutely Pure collagen peptides contain undeclared shellfish.

Moderate risk, FDA, Undeclared shellfish

Rugby Benzoyl Peroxide Wash

Benzoyl Peroxide Wash is contaminated with microbes.

Moderate risk, FDA, Contamination

Philips Spectral CT 7500

The Spectral CT 7500 may crash during a scan, causing additional radiation.

Moderate risk, FDA, Device defect

7up Tropical Beverage

7Up Tropical beverage may contain undeclared sugar.

Moderate risk, FDA, Ended, Labeling error

Penumbra System (RED 62 Reperfusion Catheter)

The Penumbra System (RED 62 Reperfusion Catheter) may fracture due to manufacturing issues.

Moderate risk, FDA, Manufacturing problem

Tandem T:Slim Mobile Application

The t:slim iOS app version 2.13 has a software issue preventing pairing with certain CGM sensors, which could lead to hypoglycemia or hyperglycemia.

Moderate risk, FDA, Software defect

Olympus Tripp-Lite DisplayPort Cables

The DisplayPort cable may cause a video dropout or blackout in high-power mode.

Moderate risk, FDA, Device defect

Quantum PureFlow Standard Heat Exchanger

The Quantum PureFlow Standard Heat Exchanger can leak blood-to-glycol.

Moderate risk, FDA, Device defect

Coco G's Spicy Cheddar Cheese Popcorn

Spicy cheddar cheese popcorn may be contaminated with Salmonella.

High risk, FDA, Salmonella

American National Red Cross Apheresis Platelets

Apheresis Platelets lacked documentation of time exposed to the Compound Absorption Device during pathogen reduction.

Low risk, FDA, Ended, Hospital use, Contamination

16 recalls that day

Sierra Nevada Cheese Graziers Raw Cheddar, Monterey Jack and Jalapeno Jack

The cheese may be contaminated with E. coli O26:H11.

High risk, FDA, E. coli

FOCUS PI Hypromellose 0.7% Formula

Focus PI Hypromellose 0.7% Formula lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Zoladex (Goserelin) Implant

Zoladex (goserelin) implant was exposed to non-temperature-controlled conditions for 25.5 hours.

Moderate risk, FDA, Processing problem

American National Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

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

Moderate risk, FDA, Ended, Hospital use, Labeling error

American National Red Cross Red Blood Cells Leukocytes Reduced Irradiated

The product was misbranded.

Moderate risk, FDA, Ended, Hospital use, Mislabeled product

American National Red Cross Red Blood Cells, Leukocytes Reduced

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

Moderate risk, FDA, Ended, Hospital use, Labeling error

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/product dimensions, with a unit packaged as 2.50 mm instead of 3.00 mm.

Moderate risk, FDA, Labeling error

Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits

The 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

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

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

American National Red Cross Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced were distributed with a misbranding issue.

Moderate risk, FDA, Ended, Hospital use, Mislabeled product, FDA event number 99788

Department of Defense - Army Blood Components

Red Blood Cells, Whole Blood, Liquid Plasma, Fresh Frozen Plasma, and Red Blood Cells, Leukocytes Reduced may have been prepared with incorrect arm preparation.

Moderate risk, FDA, Ended, Hospital use

Oklahoma Lions Eye Bank Cornea

Corneas were distributed from a donor whose eligibility determination failed to ensure the donor was free from risk factors for communicable diseases.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Eversight Cornea

Corneas were distributed from a donor who failed eligibility determination for infection risk.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

American National Red Cross Apheresis Red Blood Cells

The product was misbranded.

Moderate risk, FDA, Ended, Hospital use, Mislabeled product, FDA event number 99740

Versiti Illinois Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

24 recalls that day

Ajanta Pharma Ranolazine Extended-Release Tablets

Ajanta Pharma USA Inc. Ranolazine Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Philips MRI Scanners and Upgrade Kits

When exporting diffusion tensor imaging scans from an MR system using the Enhanced MR Dicom format, the exports contain incorrect data.

Moderate risk, FDA, Software defect

NOxBOXi Nitric Oxide Delivery System

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

Moderate risk, FDA, Manufacturing problem

Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70

The sterilization parameters listed in the Instructions for Use differ from those in the Japanese package insert.

Moderate risk, FDA, Sterility problem

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

Presource packs containing Stryker StrykeFlow PS and AHTO tube sets may leak during use, causing fluid to pool on the floor and potential slips.

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, or 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.

Moderate risk, FDA, Software defect

Volcano Philips IntraSight Plus

Philips IntraSight Plus may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Moderate risk, FDA, Software defect

Heraeus PALACOS Bone Cement Mixing and Application Systems

Palacos bone cement has a potential for monomer liquid leakage.

Moderate risk, FDA, Device defect

EnCor EnCompass Breast Biopsy and Tissue Removal System Console

The EnCor EnCompass 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 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

HeartSine Samaritan PAD Public Access Defibrillators

HeartSine samaritan PAD defibrillators were distributed without the required Maintenance Supplement, which describes an extra check every 3 months.

Low risk, FDA, Device defect

Saving Sight Cornea

Corneas were distributed without appropriate donor screening tests, risking transmission of communicable diseases.

Low risk, FDA, Ended, Hospital use, Donor screening problem

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, Ended, Hospital use, Donor screening problem

Eversight Illinois Cornea

Corneas were recovered from a donor whose eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The product did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99170

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99169

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99168

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99167

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99166

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99165