All recalls7,815 total
Contains undeclared sesame
Product contains milk, which is undeclared in the ingredient statement.
Contains undeclared sesame
Potential undeclared allergen ingredient (Wheat)
Contains undeclared sesame
Product contains milk, which is undeclared in the ingredient statement.
Contains undeclared sesame
Product contains milk, which is undeclared in the ingredient statement.
Product contains milk, which is undeclared in the ingredient statement.
Product contains milk, which is undeclared in the ingredient statement.
Contains undeclared sesame
Potential undeclared allergen ingredient (Wheat)
cGMP deviations.
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Presence of Particulate Matter.
Due a design issue where the navigated array connection geometry is incorrect.
Tyvek bag seal issue which may compromise sterility of the kit.
Due a design issue where the navigated array connection geometry is incorrect.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Out of specification for dissolution.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Products were mislabeled as the 6mm product but included the 5 mm product.
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Hard corn starch lumps were found in the product