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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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14 recalls that day

Leaseir MHR Xcell Surgical Laser Instruments

The console label for affected devices is missing the "Danger" symbol.

Moderate risk, FDA, Labeling error

Medline Semi Electric and Full Electric Homecare Beds

Medline beds have a potential hazard involving the hand control pendant and wires, which may overheat and pose a fire risk.

High risk, FDA, Device defect

Mazor Robotics Mazor X Robotic Guidance System

The Mazor X robotic guidance system has software errors that can result in incorrect surgical instrument positioning.

Moderate risk, FDA, Software defect

Southern Rocklobster Australian Greenlip Abalone

Australian Greenlip Abalone, frozen, may be contaminated with Listeria.

Moderate risk, FDA, Ended, Listeria

GE Healthcare Omni Legend PET Scanners

GE Healthcare Omni Legend can show a streaking artifact in PET scan images.

Moderate risk, FDA, Device defect

10 recalls that day

Live It Up Super Greens Dietary Supplement Powders

Live it Up Super Greens may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Ended, Salmonella

Cipla USA Lanreotide Injection

Lanreotide Injection contains particulate matter.

Moderate risk, FDA, Foreign object

ADM Animal Nutrition MasterPlex 75P 30/30 RU

MasterPlex 75P medicated feed has incorrect labeling that can cause monensin and urea toxicity.

High risk, FDA, Ended, Chemical contamination

Thoratec CentriMag Blood Pump and Kits

The CentriMag blood pump may not fit into the motor and may not lock securely, which could lead to stroke, embolism, or death.

Moderate risk, FDA, Foreign object

Hologic ThinPrep CytoLyt Solution Buffered Cell Wash Solution

ThinPrep CytoLyt Solution is contaminated with Parengyodontium album.

Moderate risk, FDA, Contamination

ICU Medical Plum Duo Infusion System

The Plum Duo Infusion System may have a defective speaker that fails to produce audible sound.

Moderate risk, FDA, Device defect

Medtronic Abre Venous Self-Expanding Stent System

The Abre Venous Self-Expanding Stent System may have reduced diameter and radial force, potentially causing migration.

Moderate risk, FDA, Device defect

Instrumentation Laboratory Coagulation Testing Reagents

The product has potential for microbial contamination.

Moderate risk, FDA, Contamination

ICU Medical Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray

ICU Medical products may have a cracked syringe collar.

Moderate risk, FDA, Device defect

Intuitive Surgical da Vinci SP Access Port Kit

The da Vinci SP Access Port Kit may develop cracks, potentially causing a sterility breach.

Moderate risk, FDA, Sterility problem

20 recalls that day

Encon Safety Products Aquarion Preserved Cartridges

The cartridges have cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Advanced Pharmaceutical Technology TESTO-100 CIII Testosterone Pellets

Testo-100 Ciii (testosterone 100 mg) pellets may be contaminated with microbes, lacking assurance of sterility.

Moderate risk, FDA, Sterility problem

C-RAD Positioning Catalyst+ Patient Positioning Devices

The Catalyst and Catalyst+ patient positioning devices may show a patient as correctly positioned when they are not, due to a system issue.

Moderate risk, FDA, Device defect

Sun Pharmaceutical Clindamycin Phosphate Topical Solution

Taro may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Philips Azurion Systems

Philips Azurion Systems R3.0 have software issues that may cause loss of X-ray and other problems.

Moderate risk, FDA, Software defect, FDA event number 98071

PALACOS Bone Cement Mixing and Application Systems

There are complaints about breakage of the ampoules within the device systems.

Moderate risk, FDA, Device defect

Healthy Truth Moringa Powder

Healthy Truth brand Moringa Powder may be contaminated with Salmonella Richmond.

High risk, FDA, Salmonella

Philips Azurion Systems

Philips Azurion Systems have software issues that may cause system restarts and positional errors.

Moderate risk, FDA, Software defect, FDA event number 98096

Sanders Candy Factory Frosted Almond

Frosted Almond contains elevated levels of aflatoxin.

Moderate risk, FDA, Ended, Chemical contamination

Ukrop's Homestyle Foods Pound Cakes with Buttercream Icing

Ukrop's pound cakes with buttercream icing may contain undeclared soy.

Moderate risk, FDA, Undeclared soy

AZ Gems Jumbo Raw Shrimp

Jumbo raw shrimp contain elevated levels of chloramphenicol.

Moderate risk, FDA, Chemical contamination

So Delicious Dairy Free Salted Caramel Cluster Cashewmilk Non-Dairy Frozen Dessert

So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert contains foreign material.

Moderate risk, FDA, Ended, Foreign object

Diagnostica Stago Asserachrom HPIA Kits

The Asserachrom HPIA kit can produce negative results due to a defect affecting every well in the impacted strip.

Moderate risk, FDA, Device defect

Fran's PureBar Almondmilk Chocolate

Fran s PureBar Almondmilk Chocolate contains undeclared hazelnut.

High risk, FDA, Ended, Undeclared tree nut

Medline Medical Procedure Convenience Kits

Medline medical procedure convenience kits can leak and emit vaporized saline that resembles smoke during use.

Moderate risk, FDA, Device defect

Troemner Family Farm Pfeffernusse Cookies

Troemner Family Farm Pfeffernusse Cookies contain undeclared soy, wheat, and milk.

High risk, FDA, Ended, Undeclared milk

One Roof Atwater's Holiday Cookie Tin

The Atwater's Holiday Cookie Tin contains undeclared tree nut allergens.

High risk, FDA, Ended, Undeclared tree nut

Alvogen Levothyroxine Sodium Tablets Thy-Tabs

Levothyroxine Sodium Tablets, USP, Thyro-Tabs may contain 88 mcg tablets instead of 150 mcg tablets.

Moderate risk, FDA, Labeling error

Gold Star Distribution Advil, Aleve, Tylenol and More Over-the-Counter Medicines

Gold Star Distribution medicines have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

WFM Purchasing Brussel Sprouts & Kale Slaw

Brussel Sprouts & Kale Slaw contains undeclared fish and egg allergen.

High risk, FDA, Ended, Undeclared egg

5 recalls that day

Philips Allura Xper FD10, FD20 and Biplane Systems

Allura Xper systems may have a missing drip tray, allowing coolant to contact electrical components and cause shutdown.

Moderate risk, FDA, Device defect

Canon Medical Vantage Galan 3T and Vantage Titan 3T MRI Systems

If a quench occurs, helium gas may not escape, and pressure in the helium vessel may rise.

Moderate risk, FDA, Device defect

Elekta MOSAIQ Oncology Information System with Particle Therapy License

The Mosaiq Oncology Information System with Particle Therapy License may deliver partial treatment twice, causing overtreatment.

Moderate risk, FDA, Foreign object

Taro Pharmaceuticals Fluocinolone Acetonide Topical Solution

Taro Pharmaceuticals Inc. Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Repligen Maverick Measurement Module Spectrometer

Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact.

Moderate risk, FDA, Device defect

6 recalls that day

Outside The Breadbox Bread Crumbs

Bread Crumbs may contain undeclared egg and milk.

High risk, FDA, Ended, Undeclared milk

Karison Besan Laddoo, Punjabi Pinni, Alsi Pinni and Panjiri

Karison brand Punjabi Pinni and other snacks contain undeclared milk, posing a risk of serious allergic reaction.

Moderate risk, FDA, Ended, Undeclared milk

Spring & Mulberry Date-Sweetened Chocolate

Spring & Mulberry Date-Sweetened Chocolate bars may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Fresenius Kabi Ivenix Infusion System LVP Software

The Ivenix Infusion System LVP Software has instructions for LVP duration programming that are emphasized in the IFU.

Moderate risk, FDA, Software defect

HANGZHOU BEVER MEDICAL DEVICES BD Ready-to-Use Hydrophilic Catheter

The BD Ready-to-Use Hydrophilic Catheter has a labeling error with an incorrect expiration date.

Moderate risk, FDA, Labeling error

Medline Kits With B. Braun IV Administration Sets

Medline kits containing B. Braun IV administration sets may have check valves that stick.

Moderate risk, FDA, Device defect

12 recalls that day

Diva Fam Sea Moss Gel Superfood

Sea Moss Gel Superfood may be contaminated with C. botulinum (botulism), which can cause botulism, a serious illness affecting the nervous system.

Moderate risk, FDA, Ended, Botulism

Herbs Forever Ayurvedic Herbal Supplements

HerbsForever Hingwastik Churna and Gastro Care dietary supplements may contain undeclared wheat, posing a risk of serious allergic reactions.

High risk, FDA, Ended, Undeclared wheat

Modern Warrior Life Ready Dietary Supplement

Modern Warrior Ready contains unapproved ingredients that can cause life-threatening events.

High risk, FDA, Hidden drug ingredient

Eureka Cinnamon

Cinnamon in a clear plastic container has elevated levels of lead.

Moderate risk, FDA, Chemical contamination