The FDA has posted 6 enforcement recalls of antimicrobial 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;…
Unapproved design changes to the products outside of the 510(k) clearance.
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;…
Surgical drape packs may have open seals, which may compromise the sterility of the product.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Drape, Surgical, Antimicrobial”). Informational only — verify against the FDA before acting.