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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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5 recalls that day

Slate Cookies & Cream High Protein Nutrition Shake

Slate Cookies & Cream High Protein Nutrition Shake has an inaccurate nutrition label on the case.

Not yet rated, FDA, Labeling error

Ethel's Bakery Gluten Free Turtle Dandy Dessert Bars

Ethel's Gluten Free Turtle Dandy Dessert Bars have incorrect product identity, inaccurate ingredient declaration, and inaccurate Nutrition Facts.

Low risk, FDA, Labeling error

7-Eleven Horchata Drink Concentrate

Sunny Sky Products has identified that analytical results for certain lots of 7-Eleven Horchata may not conform to established product requirements.

Not yet rated, FDA

Luminex LIAISON PLEX Gram-Negative Blood Culture Assay

The Liaison Plex Gram-Negative Blood Culture Assay may cause incorrect or delayed diagnosis of bloodstream infection.

Moderate risk, FDA, Device defect

Halyard Arthroscopy Pack

The Halyard Arthroscopy Pack is mislabeled as "Extremity" instead of "Arthroscopy Pack."

Moderate risk, FDA, Labeling error

4 recalls that day

GE Senographe Pristina Mammography Systems

GE Senographe Pristina Mammography Systems may show collimator blades or open more than expected in 3D+2D manual mode.

Moderate risk, FDA, Device defect

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100028

American National Red Cross Apheresis Platelets

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

Moderate risk, FDA, Ended, Hospital use, Processing problem, FDA event number 100027

Intelerad IntelePACS Software

IntelePACS software has a cybersecurity vulnerability that could allow a malicious user to take over an administrator session.

Moderate risk, FDA, Software defect

18 recalls that day

Brad's Plant Based Brad's Crunchy Kale and Veggie Chips Kale

Brad's Crunchy Kale and Veggie Chips Kale may contain thallium, which can cause serious health effects.

Not yet rated, FDA

New York Blood Center Enterprises Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated tested repeatedly reactive for anti-HCV and were distributed.

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

ImpactLife Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Ended, Hospital use

Darwin's Natural Pet Products Natural Selections Chicken Recipe for Cats

Darwin's Natural Pet Products Natural Selections Chicken Recipe for Cats may be contaminated with Salmonella.

Not yet rated, FDA, Salmonella

Sagent Pharmaceuticals Famotidine Injection

Famotidine Injection contains particulate matter.

Not yet rated, FDA, Foreign object

American Health Packaging Cyanocobalamin Injection

Cyanocobalamin Injection may contain glass particles.

Moderate risk, FDA, Contamination

Hikma Ciprofloxacin Tablets

Ciprofloxacin Tablets have N-nitroso-ciprofloxacin results above the FDA recommended interim control limit.

Moderate risk, FDA, Drug impurity

Remel Yeastone Broth

Yeastone Broth may report false susceptibility to antifungal agents.

Moderate risk, FDA, Quality testing problem

Baxter TruSystem 7500 and TruSystem 7000 U Surgical Tables

TruSystem surgical tables and operating table columns may drop unexpectedly, causing abrupt patient displacement during surgery.

Moderate risk, FDA, Device defect

Cochlear Nucleus Nexa Cochlear Implant with Contour Advance Electrode

Cochlear Nucleus Nexa cochlear implants have incomplete electrode welds, which can cause open circuits.

Moderate risk, FDA, Manufacturing problem

restor3d Veritas Reverse Total Shoulder Replacement

The Veritas Reverse Total Shoulder Replacement can dislocate, reduce range of motion, or lead to revision surgery.

Moderate risk, FDA, Device defect

Shimadzu Trinias Opera Smart, Opera Grand and Smart OBL Interventional Fluoroscopic X-Ray Systems

The mounting bolts securing the C-arm drive unit may not be torqued to specification.

Moderate risk, FDA, Device defect

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for residual white blood cells or red blood cells after an RBC spillover.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100025

American Red Cross Apheresis Platelets

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

Moderate risk, FDA, Ended, Hospital use

Henry Schein Perma Sharp Surgical Sutures

Perma Sharp Sutures lack 510(k) clearance.

Moderate risk, FDA, Unapproved product

Halyard Minor Pack

Halyard Minor Pack may have open seals on header bags, compromising sterility.

Moderate risk, FDA, Sterility problem

Corin Unity Knee ASC Modular Handle

The Unity Knee ASC Modular Handle may malfunction, causing its locking mechanism to fail.

Moderate risk, FDA, Device defect

Baxter TruSystem 7000 U and 7500 U Operating Tables

TruSystem 7000 U Operating Table and Mobile column TruSystem 7500 U may drop unexpectedly, causing patient displacement and serious injury.

Moderate risk, FDA, Device defect

7 recalls that day

Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars

Tractor Wheels Organic Toddler Soft-Baked Bars can rapidly hydrate into a dense, dry, sticky mass, posing a choking hazard for toddlers.

Not yet rated, FDA

Tychasis Coats Aloe Lotion, Creme and Liniment

Tychasis Coats Aloe Lotion, Creme and Liniment have failed stability specifications.

Moderate risk, FDA, Quality testing problem

Fresenius Medical Care DELFLEX Peritoneal Dialysis Solution

Delflex Peritoneal Dialysis Solution lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Edwards Lifesciences Commander M Delivery System

The Edwards Commander M Delivery System may have a manufacturing issue causing cardiovascular balloon rupturing.

High risk, FDA, Manufacturing problem

Cardinal Health Presource PBDS Kits with BD Alaris Pump Infusion Sets

Kits contain infusion sets which were recalled for performance issues.

High risk, FDA, Device defect

Versiti Michigan Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were quarantined due to a scale that lacked daily quality control, and were distributed before investigation completion.

Moderate risk, FDA, Ended, Hospital use

Premium Health Care Glutathione Injection Solution

Glutathione injection solution may be contaminated with bacteria.

Not yet rated, FDA, Sterility problem

12 recalls that day

365 Whole Foods Market Ashwagandha Capsules

Ashwagandha capsules may be contaminated with Salmonella, which can cause serious infections.

Not yet rated, FDA, Salmonella

Victory Medical Center Pharmacy Compounded Injectable Medications

Victory Medical Center Pharmacy Compounded Injectable Medications lack processing controls.

Moderate risk, FDA

Preferred Pharmaceuticals Artificial Tears Lubricant Eye Drops

Artificial Tears Lubricant Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

House Foods America Seitan Cubes

Bulk packaged Seitan Cubes lack an ingredient statement and allergen ingredient wheat.

High risk, FDA, Undeclared wheat

AvKARE Fludrocortisone Acetate Tablets

Avkare Fludrocortisone Acetate Tablets, USP 0.1mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Brandywine Pharmaceuticals Theophylline Extended-Release Tablets

Brandywine Pharmaceuticals Theophylline Extended-Release Tablets were recalled for cgmp deviations.

Moderate risk, FDA, Manufacturing problem

Artivion CryoPatch SynerGraft Pulmonary Human Cardiac Patch

The patch was implanted, and due to limitations of long-term in vivo data, the possibility of premature graft dysfunction cannot be excluded.

Moderate risk, FDA, Device defect

Illumina NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx Instruments

Illumina NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx Instruments have a cybersecurity vulnerability that may compromise data transmission.

Moderate risk, FDA, Software defect

Natus Embletta MPR PG Sleep Monitor

The Embletta MPR PG Multi Parameter Recorder Sleep Monitor may be unable to correctly format its internal memory.

Moderate risk, FDA, Device defect

Smith & Nephew EVOS Lateral Proximal Tibia Plate

A Partial Articular Lateral Proximal Tibia Plate implant was labeled and laser etched as a Lateral Proximal Tibia Plate.

Moderate risk, FDA, Labeling error

Accriva Diagnostics Hemochron Jr. APTT Test Cuvettes

The Hemochron Jr. APTT test cuvette may have a mispositioned or absent reagent, causing erroneous results and potential thrombosis.

Moderate risk, FDA, Device defect

Tandem Diabetes Care Tandem Mobi Insulin Pump

Tandem Mobi insulin pumps may generate false-positive occlusion alarms, suspending insulin delivery and potentially causing elevated blood glucose levels.

High risk, FDA, Device defect

9 recalls that day

Wise Wife Ground Cinnamon

Wise Wife ground cinnamon contains elevated levels of lead, which can cause permanent damage to the central nervous system in children.

Not yet rated, FDA, Chemical contamination

Direct Rx Lidocaine Ointment

Lidocaine Ointment USP, 5.0 % 50g JAR may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

MSN Laboratories Atorvastatin Calcium Tablets

Atorvastatin Calcium Tablets contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Meitheal Pharmaceuticals Vecuronium Bromide for Injection

Vecuronium Bromide for Injection lacks a warning or Rx legend on its label.

Low risk, FDA, Labeling error