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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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19 recalls that day

Food to Live Organic Powders and Mixes

Food to Live Organic Powders and Mixes may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Novartis Diovan Tablets

Diovan (valsartan) 160 mg, 90 tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Honeyville Yellow Color

The product contains undeclared Red #40.

Low risk, FDA, Undeclared color or additive

Lyle Style Bloody Mary Mix

Lyle Style Bloody Mary Mix has undeclared soy.

Moderate risk, FDA, Ended, Undeclared soy

Sheandro Vodka Tomato Sauce

The label declares cream and cheese, but milk is not declared.

Moderate risk, FDA, Ended, Undeclared milk

Apollo Care Semaglutide Injection Vials

Semaglutide sterile multi-dose vials contain particulate matter identified as nylon/polyamide and silk/proteinaceous-type material.

Moderate risk, FDA, Foreign object

Cibus Fresh, Sprig & Sprout, and Jack & Olive Brand Garden Salad

Garden Salad may be contaminated with Cyclospora.

High risk, FDA, Ended, Contamination

Thermo Fisher Diagnostics Neisseria Meningitidis Gp C Tests

Certain lots of Neisseria meningitidis Gp C 2ml/VL are not performing to criteria.

Moderate risk, FDA, Quality testing problem

Medline Micro-Kill Bleach Germicidal Bleach Wipes

Medline Micro-Kill Bleach Germicidal Bleach Wipes may have reduced bleach concentration, compromising disinfection and allowing pathogen survival.

Moderate risk, FDA, Contamination

Suncoast Communities Blood Bank Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had recently traveled to a malaria endemic area.

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

Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices

Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices may contain a perforation or tear in the sterile barrier packaging.

Moderate risk, FDA, Sterility problem

Galt Medical Boston Scientific Enhance Transcarotid/Peripheral Access Kit

The Enhance Transcarotid/Peripheral Access Kit has black depth markings that may detach from the outer sheath.

Moderate risk, FDA, Device defect

Xhibit Central Station

The Xhibit Central Station has audio/video failures due to an off-the-shelf display port component.

Moderate risk, FDA, Device defect

GORE VIABIL Short Wire Biliary Endoprosthesis

A biliary endoprosthesis is incorrectly labeled, with a 10 mm x 7 cm device labeled as a 10 mm x 10 cm device.

Moderate risk, FDA, Labeling error

Roche Navify Digital Pathology Software

The navify Digital Pathology Image Management System may show a discrepancy between an image and its metadata in the Viewer window.

Moderate risk, FDA, Device defect

BOBBY Balloon Guide Catheter

The BOBBY Balloon Guide Catheter has an increased rate of balloon pinhole defects.

Moderate risk, FDA, Device defect

Blood Assurance Pooled Cryoprecipitated AHF and Red Blood Cells

Red Blood Cells and Pooled Cryoprecipitated AHF were collected from a donor at increased risk for Creutzfeldt-Jakob Disease.

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

LifeSouth Community Blood Centers Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated were distributed without required testing for hematocrit and red cell volume.

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

The Blood Connection Apheresis Platelets, Leukocytes Reduced

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

Low risk, FDA, Ended, Hospital use, Processing problem

8 recalls that day

Zydus Mirabegron Extended-Release Tablets

Mirabegron Extended-Release Tablets contain an impurity that may be present.

Moderate risk, FDA, Drug impurity

Oribe Serene Scalp Densifying Shampoo

Oribe Serene Scalp Densifying Shampoo has microbial contamination due to presence of Pluralibacter gergoviae.

Moderate risk, FDA, Contamination

Kanni Delight Frozen Vannamei White Shrimp

Frozen white shrimp contain nitrofurans.

Low risk, FDA, Ended, Chemical contamination

Contego Medical Neuroguard IEP Carotid Stent and Balloon System

The Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System may fail to open its integrated filter.

Moderate risk, FDA, Device defect

TISSIUM COAPTIUM Connect Peripheral Nerve Repair Devices

Currently labeled shelf life of 36 months is not substantiated by real-time data.

Moderate risk, FDA, Labeling error

Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis

The Blom-Singer Classic Indwelling Voice Prosthesis has incorrect labeling.

Moderate risk, FDA, Labeling error

Instrumentation Laboratory GEM Premier 7000 and GEM Premier 5000 Blood Analyzers

The lysing bag solution of specific GEM Premier 7000 and GEM Premier 5000 lots did not have the established active ingredient concentration.

Moderate risk, FDA, Device defect

U2 Total Knee System Femoral Offset Bushings

The U2 Total Knee System femoral offset bushing has incorrect engraved numbering that could cause incorrect orientation of the implant.

Moderate risk, FDA, Device defect

14 recalls that day

Victory Medical Center Pharmacy Glutathione Injection

Glutathione (MDV) vials have elevated bacterial endotoxin levels, which could cause fevers, hypotension, inflammatory reactions, anaphylactic shock and death.

High risk, FDA, Sterility problem

Medline Hudson RCI Heated Neonatal Breathing Circuits

Neonatal and infant heated wire breathing circuits may fail sporadically.

Moderate risk, FDA, Device defect

Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base

Sura Tanmen Hot and Sour Flavor ramen noodle kits may contain undeclared fish allergen, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared fish

Central Admixture Pharmacy Services Pediatric Total Parenteral Nutrition Bags

Central Admixture Pharmacy Services is recalling its Total Parental Nutrition because of incorrect product formulation.

Low risk, FDA, Quality problem

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

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

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were distributed without platelet yield testing.

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

Siemens Healthcare Diagnostics Atellica CH Urine Albumin

Atellica CH Urine Albumin tests may give falsely depressed results for other tests and cause delays.

Moderate risk, FDA, Device defect

JINA F&C Wangshin Doenjang Soybean Paste

The allergen statement on Wangshin Doenjang Soybean Paste does not include anchovy (fish).

Moderate risk, FDA, Undeclared fish

Beckman Coulter MicroScan LabPro Panel Update Software

MicroScan LabPro V5.03 Panel Update 11 has incorrect algorithms that may affect antimicrobial susceptibility test results.

Moderate risk, FDA, Software defect

Aniara Diagnostica 5-PLASMA Bivalirudin Kits, Calibrators and Controls

The 5-Plasma Bivalirudin AMR Verification Kit, Calibrator, and Control have stability issues that degrade measurable bivalirudin.

Moderate risk, FDA, Quality testing problem

Philips Allura and Azurion X-Ray Systems

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Moderate risk, FDA, Device defect

HardyDisk AST Cefiderocol 30µg (FDC30)

HardyDisk AST Cefiderocol disks may give false-susceptible or false-resistant results in susceptibility testing, including of Pseudomonas aeruginosa.

Moderate risk, FDA, Device defect

United Orthopedic U2 and USTAR II Knee Trial and Instrument Sets

Knee prosthesis trials and adaptors may not assemble properly due to an incomplete process of the component screw.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Infinion CX Lead Kit

The Infinion CX lead kit may be exposed to stress at the anchor site, causing high impedance or lead fractures.

High risk, FDA, Device defect

16 recalls that day

Blank Slate Creamery Vegan NON-Dairy Frozen Dessert Coconut Fudge Sandwiches

Vegan non-dairy frozen dessert coconut fudge sandwiches may contain undeclared egg, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared egg

Fresenius Kabi Morphine Sulfate Injection

Morphine Sulfate Injection syringes may be mislabeled and contain Dilaudid.

High risk, FDA, Labeling error

KC Everyday Mac & Cheese

KC Everyday Mac & Cheese contains an undeclared allergen (egg).

High risk, FDA, Undeclared egg

Big Way Hot Pot Miso Paste

Big Way Hot Pot "Hot Pot Miso Paste" contains undeclared milk from lactose.

Moderate risk, FDA, Undeclared milk

Aurobindo Pharma Dicyclomine Hydrochloride Capsules

Dicyclomine Hydrochloride Capsules may be shortfilled, with reports of empty capsules.

Moderate risk, FDA, Quality problem

GE Healthcare Portrait Core Services Software

A software vulnerability in the patient monitoring system may allow unauthorized access, causing loss of monitoring and missed alarms.

Moderate risk, FDA, Software defect

Pack'n Fresh Hondashi Seasoning

Pack'n Fresh is recalling its "***Hondashi ***" seasoning packed in silver plastic/metallic pouch because of allergen missing from contains statement: fish.

Moderate risk, FDA, Undeclared fish

FilmArray NGDS Warrior Panel

The FilmArray NGDS Warrior Panel has mismatches between the outbreak strain and the reference strain used in its development.

Moderate risk, FDA, Device defect

Cheer Pack Flexible Food Pouches

Flexible food pouches may release thin plastic strips into food.

Moderate risk, FDA, Foreign object