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FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,974 recalls Dates are when each recall was announced (how we date recalls).
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4 recalls that day

Beckman Coulter DxH Diluent and DxH ECO Diluent

The diluent can cause elevated platelet background counts when used with analyzers.

Moderate risk, FDA, Device defect

Olympus Single Use Electrosurgical Knives KD-640L and KD-645

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Moderate risk, FDA, Device defect

Central Valley Medicated Cattle Feed Supplements

Cattle feed formulations contain incorrect levels of thiamine and selenium, posing potential selenium toxicity.

High risk, FDA, Wrong nutrient levels

6 recalls that day

BD Alaris Pump Module Model 8100

The BD Alaris Pump Module may have a date and time issue that can cause connectivity problems with hospital networks.

Moderate risk, FDA, Device defect

Goldenroot Ginger Beers

Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.

Moderate risk, FDA, Ended, Processing problem

Philips Ingenia, MR 7700 and Evolution MR Systems

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer PACS.

Moderate risk, FDA, Device defect

LimFlow Vector

The LimFlow Vector has an incorrect expiration date.

Moderate risk, FDA, Labeling error

LSL Healthcare Central Line Dressing Kit

The Central Line Dressing Kit contains BD ChloraPrep Triple Swabsticks with an open seal on the applicator packaging.

Moderate risk, FDA, Device defect

Miach Orthopaedics BEAR Implant

The BEAR Implant has an incorrect expiration date on its label, extending beyond its approved shelf life.

Moderate risk, FDA, Labeling error

10 recalls that day

Why Not Natural Moringa Capsules

Why Not Natural Moringa Capsules may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Ended, Salmonella

Neogen Hycoat Hyaluronate Sodium Sterile Solution

Hycoat Hyaluronate Sodium Sterile Solution may be contaminated with microbes and could cause infection in animals.

High risk, FDA, Sterility problem

Akkarco Ashfiat Alharamain Energy Support

Ashfiat Alharamain Energy Support contains undeclared tadalafil, which may pose health risks.

High risk, FDA, Hidden drug ingredient

Hannaford Hamburger Dill Pickle Chips

Hannaford hamburger dill pickle chips contain glass.

Moderate risk, FDA, Foreign object

Greenstone Methylprednisolone Tablets Dosepak

Methylprednisolone tablets have incorrect dosing information on the blister foil.

Moderate risk, FDA, Labeling error

Novadoz Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Broselow Pediatric Emergency Tape and Organizers

Broselow Pediatric Emergency Tape and Organizers contain potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

High risk, FDA, Device defect

Medline Medical Procedure Convenience Kits

Medline kits contain Mastisol liquid adhesive, and there were complaints that its butyrate tubing cracked during actuation of the vials.

Moderate risk, FDA, Device defect

Cardinal Health Chest Drainage Units and Accessories

Chest drainage units may not show tidaling or bubbling when used on infants, which can lead to inadequate treatment and prolonged hospitalization.

Moderate risk, FDA, Device defect

Zimmer Tourniquet Systems A.T.S. 5000TS and 3200TS Tourniquet Systems

A.T.S. tourniquet systems may freeze or become unresponsive in certain non-English settings, causing delays.

Moderate risk, FDA, Device defect

6 recalls that day

Koi Koi Trading Frozen Fish Balls

Frozen fish balls may contain undeclared wheat and sesame, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared wheat

Canon Alphenix Interventional Fluoroscopic X-Ray Systems

Alphenix Infx-8000C, Infx-8000F, Infx-8000H, and INFX-8000V interventional fluoroscopic x-ray systems may have loose fixing screws in the ceiling suspended arm.

Moderate risk, FDA, Device defect

NIPRO Technical Services Conductivity Standard Solutions

Conductivity Standard Solution has a defect that can cause incorrect conductivity values for dialysate.

Moderate risk, FDA, Device defect

Sato INON ACE Antacid Tablets

Failed Disintegration Specifications: above the time expected.

Moderate risk, FDA, Quality testing problem

Gold Star Distribution Bandages, Condoms, Feminine Hygiene Products, Toothbrushes and Pregnancy Tests

Gold Star Distribution tests may have been exposed to rodents and rodent activity.

Moderate risk, FDA, Foreign object

Siemens LUMINOS Q.Namix R and Q.Namix T Interventional Fluoroscopic X-Ray Systems

Ortho images acquired with preset automatic horizontal flip are not flipped.

Moderate risk, FDA, Device defect

4 recalls that day

Gerber Arrowroot Biscuits

Gerber Arrowroot Biscuits may contain soft plastic or paper pieces that should not be consumed.

Moderate risk, FDA, Contamination

Higher Harvest by H-E-B Dairy Free Coconut Based Strawberry Yogurt

Dairy Free Coconut Based Yogurt contains undeclared almonds.

Moderate risk, FDA, Ended, Undeclared tree nut

Haleon Parodontax Active Gum Health Mouthwash

Parodontax mouthwash may have missing or illegible lot and expiration date coding on the bottles.

Low risk, FDA, Labeling error

Aju Pharm Fixone, Genesis and AlternatiV+ Anchors

The Fixone Hybrid Anchor can fail, including breakage, bending, pull out, and suture breakage.

Moderate risk, FDA, Device defect

8 recalls that day

Navitas Organics Organic Chia Seeds

Organic chia seeds may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

IKM Metal Cookware Items

IKM Metal Cookware Items may be contaminated with lead, which can cause serious health problems.

Not yet rated, FDA

Elekta Synergy, Harmony, Infinity and Versa HD Linear Accelerators

Elekta Synergy, Harmony, Infinity, and Versa HD linear accelerators have a manufacturing issue with electrical grounding.

Moderate risk, FDA, Manufacturing problem

McCafe Premium Roast Decaf Coffee K-Cup Pods

McCafe Premium Roast Decaf Coffee K-Cup Pods are labeled as decaf but might contain caffeine.

Moderate risk, FDA, Ended, Labeling error

Bharat Bazar Soma Kitchen Natural Asafoetida

Soma Kitchen Natural Asafoetida contains undeclared wheat.

Moderate risk, FDA, Undeclared wheat

Baxter Sterile Water for Irrigation

Sterile Water for Irrigation contains plastic particles from the bottle rim floating into the solution.

Moderate risk, FDA, Foreign object

Qunol Extra Strength Turmeric Capsules

Qunol Extra Strength Turmeric Capsules may contain mold contamination.

Moderate risk, FDA, Contamination

Cerapedics PearMatrix P-15 Peptide Enhanced Bone Graft

PearMatrix P-15 Peptide Enhanced Bone Graft has an incorrect expiration date.

Moderate risk, FDA, Labeling error

8 recalls that day

Edan Fetal, Maternal, Vital Signs and Patient Monitors

The devices have potential cybersecurity issues.

Moderate risk, FDA, Software defect

White Castle Original Sliders

White Castle Original Sliders contain undeclared milk and soy allergens.

High risk, FDA, Ended, Undeclared milk

Community Products Rifton Equipment TRAM and E-Pacer Powered Lifts

The TRAM powered lift device has a potential for fraying on the body support strap.

Moderate risk, FDA, Device defect

GVS TM SQ40S Blood Transfusion Filter

The SQ40S Blood Transfusion Filter was released before required quality control was completed, so sterility cannot be confirmed.

Moderate risk, FDA, Sterility problem

Catao Market Gaceniga Authentic Cuban Loaf Cakes

Gaceniga Authentic Cuban Loaf Cakes in Classic and Raisins varieties contain undeclared FD&C Yellow #5.

Moderate risk, FDA, Ended, Undeclared color or additive

Philips Patient Information Center iX

Patient Information Center iX software can modify filter settings without user indication.

Moderate risk, FDA, Software defect

Gold Star Distribution Human Food Products

All human food products may have been exposed to rodents and rodent activity.

Moderate risk, FDA, Foreign object

Zydus Pharmaceuticals Icosapent Ethyl Capsules

Zydus Pharmaceuticals Icosapent Ethyl capsules may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

10 recalls that day

Rising Pharmaceuticals Furosemide Tablets

Furosemide Tablets contain a foreign substance.

Moderate risk, FDA, Foreign object

Specialty Process Labs Thyroid USP

Thyroid, USP may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Beckman Coulter LDL-Cholesterol Assay

The LDL Cholesterol reagent is not meeting its performance claim.

Moderate risk, FDA, Device defect

Bakkavor Meal Simple Red Lentil Dal Soup

Red lentil dal soup contains undeclared milk and the wrong product in the container.

Moderate risk, FDA, Undeclared milk

Lily's Bakery Factory Cuban Crackers Galletas Cubanas

Cuban Crackers Galletas Cubanas contain undeclared colors.

Moderate risk, FDA, Ended, Undeclared color or additive