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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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25 recalls that day

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, Ended, Hospital use, Donor screening problem

ForeSight Elite Tissue Oximetry Cable

The ForeSight Elite Tissue Oximetry Cable has incorrect switching of Channel 1 and 2 and flag labels.

Moderate risk, FDA, Labeling error

Abiomed Impella Controllers

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

Moderate risk, FDA, Software defect

CorneaGen - Boston Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99913

Iowa Lions Eye Bank Cornea

Corneas processed using an expired viewing chamber were distributed.

Moderate risk, FDA, Ended, Hospital use

CorneaGen - Boston 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, FDA event number 99922

OneLegacy 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

Rocky Mountain Lions Eye Bank Cornea

Corneas were distributed without adequate donor eligibility determination.

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

Eversight Cornea

Cornea was distributed when donor eligibility was not adequately determined.

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

Precision Ocular Network - Bartlett Cornea

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

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99916

Precision Ocular Network - Bartlett Cornea

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

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99915

Eversight Illinois Cornea

Corneas were not tested adequately to reduce the risk of transmitting communicable diseases.

Low risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99912

Department of Defense Navy Whole Blood

Whole Blood tested negative for a virus antibody but was collected from a donor who previously tested positive.

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

HCSC-Blood Center Apheresis Platelets, Leukocytes Reduced

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

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

Mississippi Blood Services Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor with low hemoglobin or no hemoglobin check.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98849

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, Ended, Hospital use, Donor screening problem, FDA event number 98848

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

The product did not meet specifications.

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

Eversight Illinois Cornea

Cornea was processed without the proper antibiotic soak.

Moderate risk, FDA, Ended, Hospital use, Processing problem, FDA event number 95801

18 recalls that day

GF Blends Gluten Free Baking Mixes

GF Blends is recalling its GF Blends because products are recalled due to potential undeclared wheat gluten.

High risk, FDA, Undeclared wheat

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

Philips Achieva, Ingenia, Intera and MR MRI Systems

A software issue in Philips MR systems will terminate an examination if reconstruction requirements exceed available system memory.

Moderate risk, FDA, Software defect

Pearle Vision 1 day (Somofilcon A) Contact Lens

Pearle Vision 1 day contact lenses have incorrect power in a small number of lenses.

Moderate risk, FDA, Device defect

bioMérieux VITEK 2 AST-N461 Test Kit

The Vitek 2 AST-N461 test kit may give false resistant results due to card pouch damage, potentially leading to less effective antibiotic treatments.

Moderate risk, FDA, Device defect

Medline Convenience Kits Containing Healthmark Instrument Channel Brushes

Medline convenience kits containing Healthmark Instrument Channel Brushes may have a sharp edge that can cause cut injury and infection.

Moderate risk, FDA, Device defect

Philips EPIQ Elite Diagnostic Ultrasound System

The Philips EPIQ Elite Diagnostic Ultrasound System has a software issue that can cause inaccurate blood flow velocity 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 proximal thread depth of the spinal device is out of design specification.

Moderate risk, FDA, Device defect

HomeFill Oxygen Cylinders

HomeFill Oxygen Cylinders do not carry the required medical gas labeling.

Moderate risk, FDA, Labeling error

CooperSurgical INCA Infant Nasal CPAP Sets

CooperSurgical INCA Infant Nasal CPAP Sets may exhibit a loose connection between the flexible tubing and the nasal cannula during assembly or use.

High risk, FDA, Device defect

Midmark IQvitals Zone

The Midmark IQvitals Zone may give inaccurate blood pressure readings when using the Linear Deflation Method.

Moderate risk, FDA, Device defect

Olympus EZDilate Endoscopic Balloon Dilators

The inflation chart label on the shaft of the EZDilate Endoscopic Balloon Dilator may show an incorrect balloon diameter.

Moderate risk, FDA, Labeling error

Menow Sunscreen Pressed Powder SPF35 PA+++

The product has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Olympus BiCOAG Hemostasis Probe

The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.

Moderate risk, FDA, Device defect

Heidelberg Engineering SPECTRALIS with Flex Module

The Spectralis with Flex Module may have wheels that come loose, causing the stand to tip over and possibly cause impact or crushing injuries.

Moderate risk, FDA, Device defect

9 recalls that day

ICU Medical 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection may be mixed up with potassium chloride.

High risk, FDA, Labeling error

Heinz Real - Vraie Mayonnaise

The product contains tarter sauce, resulting in undeclared ingredients including mustard and soybean oil.

Moderate risk, FDA, Undeclared soy

Mon Sire Brie, Soft-Ripened French Cheese

Mon Sire Brie, soft-ripened French cheese, may contain Listeria.

High risk, FDA, Listeria

Hospira Dopamine HCl Injection

Dopamine HCl injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Hexing Haw Balls Candy

Hexing Haw Balls candy contains an unapproved dye.

Low risk, FDA, Undeclared color or additive

Dechra Veterinary Products Puralube Vet Ointment

The product has cGMP deviations. It may not be sterile.

Moderate risk, FDA, Manufacturing problem

Pi-Cardia ShortCut Device

The ShortCut transfemoral catheter has a weld issue that may cause the positioning arm to detach.

Moderate risk, FDA, Device defect

CADD Yellow Medication Cassette Reservoir with NRFit Connector

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing.

Moderate risk, FDA, Device defect

F & A Foundation Reign Medical Clench Staple System (Compression)

The Reign Medical Clench Staple System (Compression) has not had its performance characteristics adequately established.

Moderate risk, FDA, Device defect

19 recalls that day

J. HIGGS Loaded Bacon & Cheddar Potato Chips

J. Higgs Loaded Bacon & Cheddar Potato Chips may contain undeclared soy, posing a risk of serious allergic reaction.

Moderate risk, FDA, Ended, Undeclared soy

Inventia Healthcare Chlorthalidone Tablets

Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Michelle's Bakery Pumpkin Spice No Bake Cookies

Pumpkin spice no bake cookies have peanuts omitted from the contain statement and eggs listed but not present.

Moderate risk, FDA, Undeclared peanut