All consumer recall records

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg st...

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Missing from associated official evidence: action.

One Step K in vitro diagnostic test REF: 81A4

The devices were distributed without required FDA premarket clearance or approval.

Missing from associated official evidence: action, consumer scope.

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

Missing from associated official evidence: action.

RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGER...

Multi-state outbreak of E. coli O157:H7.

Missing from associated official evidence: action.

See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to...

Missing from associated official evidence: action.

SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC: 086700030561

Potential contamination with pesticides, haloxyfop and thiamethoxam

Missing from associated official evidence: action.

TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection,...

Incorrect Product Formulation: product did not contain insulin as listed in the label.

Missing from associated official evidence: action.

VOCSN V+Pro package, REF: PRT-01198-000

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below inte...

Missing from associated official evidence: action, consumer scope.

Allura Imports Youth Sweatshirts with Bobcat Logo and Drawstrings

The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children from strangulation. The sweatshirts are in violation of the federal regulations for children's upper outerwear and present a substantial product...

Analemma Water Bottles Recalled

The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards.

EEMB USA Battery Pouches

The lithium coin batteries are in pouches that are not child-resistant as required under Reese's Law. If a child swallows button cell or coin batteries, the ingested batteries can cause serious injuries, including internal chemical burns and death.

EVLWZL and Gunugu Mattresses Recalled

The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.

Favoto Bicycle Helmets Recalled

The recalled helmets violate the mandatory safety standard for bicycle helmets because they do not comply with the positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a seri...

Multi-Purpose Helmets Recalled

The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious...

Natural Pigments Rublev Colours Gum Turpentine and Mineral Spirits Bottles

The gum turpentine and mineral spirits contain turpentine and low-viscosity hydrocarbons, respectively, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of ser...

Rainbow Wall Toys Recalled

The recalled toys violate the mandatory safety standard for children's toys because the drumstick that is attached to the xylophone component has a spherical end that can pose a choking hazard.

Svnntaa Bed Rails Recalled

The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiat...

ZMC Group Multiple Light Up Toys

The recalled toys violate the mandatory safety standard for children's toys because the toy contains button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious inju...

52USA brand POPPING BOBA

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

Missing from associated official evidence: action.

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc.,...

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

Missing from associated official evidence: action.

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

Missing from associated official evidence: action, consumer scope.

Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package

product tested positive for Listeria Monocytogenes.

Missing from associated official evidence: action.

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber...

Missing from associated official evidence: action.

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software...

It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AA...

Missing from associated official evidence: action, consumer scope.