Foreign material.
All Recalls
95,018 total recalls in our database
Foreign material.
Foreign material.
Label declares butter and ghee but does not declare milk.
Foreign material.
Label has a Contains statement that is missing milk and coconut (tree nut) that are declared in the ingredients statement.
Label declares butter and ghee but does not declare milk.
Asli Cinnamon Powder, 7oz clear plastic pouch, UPC 703440150723
Sands Impex Inc.
Lead contamination
Foreign material.
6.5oz Emerald Kettle Glazed Walnut, UPC: 0 10300 80894 7
Flagstone Foods
undeclared peanuts, almonds and pecans
Foreign material.
LABELING: LABEL MIX-UP.
Microbial contamination of non-sterile Products -
XXX
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490
Siemens Healthcare Diagnostics
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
MEDLINE INDUSTRIES, LP - Northfield
Potential for an incomplete seal on the packaging tray.
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
MEDLINE INDUSTRIES, LP - Northfield
Potential for an incomplete seal on the packaging tray.
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.