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Medline Industries, LP recalls See complete list in RES, exceeds character limit. Medline Surgical Gowns
Recalled May 13, 2026 · FDA recall Z-2129-2026 · Medline Industries
Hazard
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; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. · FDA Class II
Units
70376042 units
Sold at
Worldwide - US Nationwide distribution.
Description
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; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Product
See complete list in RES, exceeds character limit. Medline Surgical Gowns
Manufacturer(s)
Medline Industries, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →