The FDA has posted 5 enforcement recalls of sterile specimen container devices since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
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;…
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
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;…
Potential for microbial contamination.
Potential for microbial contamination.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Container, Specimen, Sterile”). Informational only — verify against the FDA before acting.