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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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4 recalls that day

Ghirardelli Frappe Mixes, Sweet Ground Powders and Hot Cocoa Mix

Ghirardelli Frappe Mixes, Sweet Ground Powders and Hot Cocoa Mix have the potential to be contaminated with Salmonella.

High risk, FDA, Salmonella

Philips MRI Systems with MR Elastography

Philips Achieva 1.5T with MR Elastography (MRE) may show stiffness values that are too small.

Moderate risk, FDA, Software defect

Hemu Trading Enoki Mushrooms

Enoki mushrooms tested positive for Listeria.

High risk, FDA, Ended, Listeria

HiResolution Bionic Ear System M Zn-Air Battery Pak

The M Zn-Air Battery Pak has a battery door that fails to require a tool for replacement.

Moderate risk, FDA, Device defect

11 recalls that day

Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix

Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix contains undeclared allergens that can cause serious or life-threatening allergic reactions.

Moderate risk, FDA, Undeclared milk

GenTeal Tears and Systane Lubricant Eye Gel

Systane and GenTeal lubricant eye gels may lack sterility, which can impact product quality.

Moderate risk, FDA, Sterility problem

52USA Popping Boba

52USA brand Popping Boba contains unapproved colors.

Moderate risk, FDA, Undeclared color or additive

Medtronic Sphere-9 Catheter

The Medtronic Sphere-9 Catheter can cause ventricular fibrillation during therapy in patients with certain Biotronik defibrillators.

Moderate risk, FDA, Device defect

Zimmer Disposable Mixing Bowls with Spatula

Disposable Mixing Bowls with Spatula have package seal issues that may lead to infection.

Moderate risk, FDA, Sterility problem

Milestone Vacuum Bag SU Large Specimen Containers

The non-sterile specimen container may have reagent leakage.

Moderate risk, FDA, Device defect

Healthmark Mesh Style Tip Protectors

Mesh Style Tip Protectors lack FDA clearance.

Moderate risk, FDA, Unapproved product

Boston Scientific Essentio, Proponent, Valitude and Visionist Pacemakers

Updated software is available for the Accolade family of pacemakers and CRT-Ps, and the advisory population is expanding to include all CRT-P and DR-EL devices.

High risk, FDA, Software defect

Kiwi Omni Vacuum Delivery System

Due to complaints of device breakage at the traction force gauge to handle joint.

Moderate risk, FDA, Device defect

Genius Review Station Display (Barco Monitor)

The Genius Review Station Display may be operated outside its validated configuration due to user modification of settings.

Moderate risk, FDA, Device defect

WHILL Model C2 and Model F Powered Wheelchairs

Cyber vulnerability of BLE communication was found by Cisa VDP program.

High risk, FDA, Device defect

6 recalls that day

Frederik's by Meijer Vanilla Bourbon Trail Mix

Frederik's by Meijer Vanilla Bourbon Trail Mix may contain undeclared wheat and soy, posing a risk of serious allergic reaction.

Moderate risk, FDA, Ended, Undeclared wheat

French Broad Chocolate Bette's Bake Sale Bonbon Assortment

Bette's Bake Sale bonbon assortment may contain undeclared walnuts, which can cause serious allergic reactions.

High risk, FDA, Ended, Undeclared tree nut

El Mexicano Horchata Drinks

El Mexicano Horchata Drinks have undeclared milk.

Moderate risk, FDA, Undeclared milk

Protocol Configuration Tool (PCT) Software v1.3.0 for Hamilton AutoLys STAR

Hamilton HxRunControl software may have spontaneous closures during Autolys protocols after deployment of the PCT software.

Moderate risk, FDA, Software defect

Diversatek Healthcare Viper 3-Stage Fixed Wire and Wire Guided Balloon Dilator

The balloon dilator's inflation tag may have incorrect part numbers and sizes.

Moderate risk, FDA, Labeling error

Summit Import Spice Powder

Spice Powder has a lead level higher than the standard.

Moderate risk, FDA, Ended, Chemical contamination

12 recalls that day

Heritage Animal Nutrition Medicated Feed

Heritage Animal Nutrition Medicated Feed may contain rumensin contamination.

High risk, FDA, Ended, Chemical contamination

Kirkland Signature Traditional Madeleines

Kirkland Signature Traditional Madeleines have undeclared hazelnut and soy lecithin.

High risk, FDA, Ended, Undeclared tree nut

B. Braun Sterile Water, Dextrose, Sodium Chloride and Lactated Ringer's Injections and Irrigation

B Braun Medical products lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Windstone Medical Packaging Custom Convenience Kits Pre Op Kits

The kits contain B Braun IV administration sets with potential for backflow of medication from secondary IV containers into primary IV containers.

Moderate risk, FDA, Device defect

Micro-X Rover Mobile X-Ray System

The Rover Mobile X-ray System may malfunction, causing the X-ray to be inoperable.

Moderate risk, FDA, Device defect

Oxoid Agglutinating Sera, Salmonella 9-0

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 may cross-react with 2-0 within 60 seconds, potentially causing misidentification of Salmonella serotypes.

Moderate risk, FDA, Quality testing problem

Foundation Medicine FoundationOne CDx Sequencing Agent

Sequencing Agent SEQ0067, component of FoundationOne CDx, may increase phasing, potentially causing false-positive BARD1 splice site indel artifact variants.

Moderate risk, FDA, Device defect

LSL Healthcare Central Line Dressing, Foley Urine Collection, IV Start and Wound Closure Kits

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Moderate risk, FDA, Sterility problem

Arrow International Catheters and Introducer Kits

Arrow International is recalling its Arrow because receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured.

Moderate risk, FDA, Device defect

Beckman Coulter Access Total T4 Calibrator

Access Total T4 Calibrator has a negative bias, causing false low results.

Moderate risk, FDA, Device defect

SurgiSmoke Solutions Flamingo Funnel

Certain lots of Flamingo Funnel were made with a drape that is not compatible with gamma sterilization.

Moderate risk, FDA, Manufacturing problem

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes

The OER-ELITE Endoscope Reprocessor Connecting Tubes may have lock levers that fail prematurely.

Moderate risk, FDA, Device defect

4 recalls that day

Bombay Kitchen Punjabi Mix and Tikka Sev

Bombay Kitchen Punjabi Mix and Tikka Sev contain undeclared Yellow 6 and Red 40.

Moderate risk, FDA, Ended, Undeclared color or additive

nanOss 3D Advanced Bone Graft Substitute

The bone graft substitutes were incorrectly labeled with a 5-year shelf life, but the approved shelf life is four years.

Moderate risk, FDA, Labeling error

Leading Pharma Furosemide Tablets

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Moderate risk, FDA, Drug impurity

Davol Avitene Ultrafoam Microfibrillar Collagen Hemostat

Avitene Ultrafoam Microfibrillar Collagen Hemostat may contain foreign matter, confirmed to be inspect fragments.

Moderate risk, FDA, Foreign object

1 recall that day

Premier Monsel's Ferric Subsulfate Solution

Monsel's Ferric Subsulfate Solution has an incorrect expiration date printed on the vial.

Low risk, FDA, Labeling error

13 recalls that day

Breeder's Edge Foster Care and Shelter's Choice Milk Replacer

Breeder's Edge Foster Care Puppy Milk Replacer and Shelter's Choice Milk Replacer may have vitamin D levels higher or lower than labeled.

High risk, FDA, Ended, Wrong nutrient levels

Uvlizer Ultraviolet-C Germicidal Wands

A handheld ultraviolet-C germicidal wand can expose nearby persons to UVC radiation above recommended limits.

Moderate risk, FDA, Device defect

Major Pharmaceuticals Omega-3-Acid Ethyl Esters Capsules

The capsules failed capsule specifications for loss on drying of capsule shells.

Moderate risk, FDA, Quality testing problem

Uvlizer Handheld Ultraviolet-C Germicidal Wands

The handheld ultraviolet-C germicidal wand can expose nearby persons to ultraviolet-C radiation at levels above safety guidelines.

Moderate risk, FDA, Device defect

Teva Claravis Isotretinoin Capsules

Teva Pharmaceuticals Claravis (isotretinoin capsule, USP), 10 mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Camber Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium tablets have discolored spots.

Moderate risk, FDA, Quality problem

Salute Seasonings Ground All Spice

Ground All Spice may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Medline Guidewires, Syringes and Kits

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Moderate risk, FDA, Device defect

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Medline Convenience Kits with polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

Olympus Thunderbeat II Shears w/Ultrasonic Mode

Olympus Thunderbeat II Shears w/Ultrasonic Mode may have a distal tip component that detaches during use.

Moderate risk, FDA, Device defect

Magellan Diagnostics LeadCare Blood Lead Test Kits

LeadCare blood lead test kits may show falsely elevated results when used with certain third-party collection devices.

Moderate risk, FDA, Device defect

Integra LifeSciences CUSA Clarity C7000 Console

The CUSA Clarity C7000 Console has a software issue that renders the touch screen unresponsive.

Moderate risk, FDA, Software defect