The FDA has posted 5 enforcement recalls of exempt surgical drape 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;…
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care.…
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;…
Due to non-sterile products being labeled as sterile
Potential breach in pouch packaging which could lead to loss of sterility.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Drape, Surgical, Exempt”). Informational only — verify against the FDA before acting.