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Recall

Class II — Kimberly-Clark Corporation

Recalling firmKIMBERLY-CLARK CORPORATION
Registered facilityKIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonComplaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
ProductMicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
Quantity79,941 units
DistributionNationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
Initiated2009-09-17
Classified2012-07-16
Terminated2012-07-19
Recall numberZ-2017-2012
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Kimberly-Clark Corporation (Z-2017-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62451/

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