95,025 total recalls in our database
Collagen Matrix
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
MEDLINE INDUSTRIES, LP - Northfield
Product stored incorrectly in temperature controlled setting instead of refrigeration.
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Unknown Manufacturer
Surface paint on the brown bell found in "Day 10" of the advent calendar contains levels of lead that exceed the federal lead paint ban, posing a risk of lead poisoning. Excessive levels of lead can be toxic or cause other health problems to young children if the paint is ingested.
Unknown Manufacturer
The lithium-ion battery in the Ionic smartwatch can overheat, posing a burn hazard.
Unknown Manufacturer
The user's rope can get caught or wedged in the PIRANA blocking slot and stop or suspend the climber, posing a drowning risk if they are under a waterfall or pool.
Unknown Manufacturer
The metal zipper slider, zipper 0-ring, d-ring, rivet and stud of the children's handbags contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
Potential to contain undeclared peanuts
Hazelnuts were packaged and mis-labeled as cashews. Hazelnuts are visible through the package.
Frozen Food Development
Possible contamination of Listeria monocytogenes in frozen chopped spinach.
Michigan Department of Agriculture and Rural Development sampled product and Listeria monocytogenes was detected.
Driscoll s identified specific lots of strawberries exceeding the United States Maximum Residual Limit (MRL) for the pesticide Etoxazole. Analytical results included residue level between 1.20 to 1.28 ppm
Je Dois Lavoir
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
cGMP Deviations
SUN PHARMACEUTICAL INDUSTRIES
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
ABC Sales 1
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
cGMP Deviations
Your Favorite Shop
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.