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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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10 recalls that day

Vitek 2 AST-N447 Test Kit

The Vitek 2 AST-N447 test kit may give false resistant results when pouch foil is fractured.

Moderate risk, FDA, Device defect

OmniTract Surgical Retractor System

The OmniTract Surgical Retractor System has a dry time that needs to be extended.

Moderate risk, FDA, Sterility problem

GSP Neonatal GALT Kit

Reduction in the on-board stability of the GSP Galt assay.

Moderate risk, FDA, Device defect

Elekta Brachytherapy Applicators

The tip of the intrauterine tube may detach and remain within a patient.

Moderate risk, FDA, Device defect

Mississippi Blood Services Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced lack documentation of acceptable storage temperature.

Moderate risk, FDA, Ended, Hospital use

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99180

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99179

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

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

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99178

13 recalls that day

Somerset Therapeutics Pemetrexed, Bortezomib and Azacitidine for Injection

Reliance Life Sciences Private products lack sterility assurance.

Moderate risk, FDA, Manufacturing problem

KL Owen Custom Orthodontic Solution

KL Owen Custom Orthodontic Solution may have a defect causing incorrect bracket placement.

Moderate risk, FDA, Device defect

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

The assay has potential for intermittent well-to-well bias.

Moderate risk, FDA, Device defect

MiniMed 780G Insulin Pump

The insulin pump can stop delivering insulin due to a software anomaly, which may lead to hyperglycemia or diabetic ketoacidosis.

Moderate risk, FDA, Software defect

Medline Convenience Kits

Medline Convenience Kits contain a temperature probe that has been recalled due to a distribution control error.

Moderate risk, FDA, Device defect

Gasco and Drogueria San Juan Isopropyl Alcohol

Gasco and Drogueria San Juan Isopropyl Alcohol may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Fresenius Medical Care 5008X Blood Tubing Sets

The 5008X Blood Tubing Set may have connection issues that can cause errors.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Intracept Access Instruments

Intracept Access Instruments may have a sterile barrier breach of the outer tray seal, which could lead to severe infection.

Moderate risk, FDA, Sterility problem

Encore Medical EMPOWR 3D Knee Implants

Due to packaging discrepancy with incorrect product size mixed up.

Moderate risk, FDA, Packaging defect

LifeServe Blood Center Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were manufactured with an unknown quantity of additive solution.

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

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 99177

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99175

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99174

16 recalls that day

Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated were not tested to verify white blood cell count.

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

Fresh to You Burger Chicken Fillet

Fresh to You Burger Chicken Fillet may contain raw breaded chicken patties, posing a risk of Salmonella foodborne illness.

High risk, FDA, Ended, Salmonella

Trafa Pharmaceuticals Organic Moringa Leaf Powder

Organic moringa leaf powder may be contaminated with Salmonella.

High risk, FDA, Salmonella

QuVa Pharma Methohexital Sodium

Methohexital Sodium failed impurities and degradation specifications.

Moderate risk, FDA, Drug impurity

Giant Vanilla Dessert Shells

Vanilla Dessert Shells contain undeclared soy.

Moderate risk, FDA, Ended, Undeclared soy

Wondermade Alabama Banana Pudding Marshmallows

Alabama Banana Pudding Marshmallow may contain small metal pieces.

Moderate risk, FDA, Ended, Foreign object

Medline Remedy Specialized Silicone Cream (Hydraguard-D)

Medline Remedy Specialized Silicone Cream (Hydraguard-D) may contain more impurities than allowed.

Moderate risk, FDA, Quality testing problem

Shimoga Chemicals Clomiphene Citrate Active Pharmaceutical Ingredient

The product has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Beauty Pie Super Healthy Hair Blow Dry Spray

Super Healthy Hair Blow Dry Spray Coconut Water Heat Shield Styler may be contaminated with Pseudomonas aeruginosa.

Moderate risk, FDA, Contamination

Avet Methohexital Sodium for Injection

Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

ConvaTec Aquacel Ag Surgical SP

The surgical dressing was manufactured out of specification.

Moderate risk, FDA, Quality testing problem

Wise Onion Rings

Wise Onion Rings contain undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.

Moderate risk, FDA, Ended, Undeclared color or additive

Olympus Single Use Distal Cover

The Olympus Single Use Distal Cover has a newly designed version to replace the previous design.

Moderate risk, FDA, Device defect

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 99173

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99172

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99171

5 recalls that day

Fayus Ola-Ola Pounded Yam

OLA-OLA Pounded Yam contains undeclared milk, which can cause serious or life-threatening allergic reactions in people with milk allergy.

High risk, FDA, Undeclared milk

Adams Extract & Spice Seasonings and Mixes

Adams Extract & Spice Seasonings and Mixes have undeclared sesame allergen.

High risk, FDA, Ended, Undeclared sesame

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The platelets did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99163

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99161

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99160

1 recall that day

Frutas y Hortalizas del Sur Organic Whole Blueberries

Frozen organic blueberries and berry blends may be contaminated with E. coli O145:H28, which can cause severe stomach cramps, diarrhea, and vomiting.

High risk, FDA, E. coli

21 recalls that day

Fusia Asian Inspirations Kimbap

Fusia Asian Inspirations Kimchi & Tofu Kimbap may contain undeclared fish, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared fish

Pedigree High Protein Chopped Ground Dinner Chicken & Duck Flavor

Pedigree High Protein Chopped Ground Dinner Chicken & Duck Flavor may contain metal and plastic foreign material, posing a hazard to dogs.

Moderate risk, FDA, Foreign object

Cipla Cinacalcet Hydrochloride Tablets

The tablets contain N-nitroso-cinacalcet above the acceptable daily intake.

Moderate risk, FDA, Drug impurity

Lannett Dextroamphetamine and Amphetamine Extended-Release Capsules

Extended-release capsules labeled as such contain only immediate-release pellets.

Moderate risk, FDA, Labeling error

Enovachem Pharmaceuticals Lidocaine HCl Injection

Accucaine kits and Lidocaine HCl Injection lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Zimmer Biomet A.T.S. 4000 TS Tourniquet System Sterile Hoses

Sterile tourniquet hoses may have a sterility breach in the sealing area, potentially causing moderate localized infection.

Moderate risk, FDA, Sterility problem

GORE TAG Thoracic Branch Endoprosthesis Side Branch Component

The Gore TAG Thoracic Branch Endoprosthesis Side Branch Component can separate due to catheter separation.

Moderate risk, FDA, Device defect