Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–31 of 31 recalls
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils.…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process.…
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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.
Sterility assurance with procedure trays
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and St…