FDA Device recall Z-2017-2012

MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras

FDA Device
Class II
terminated
Published 2012-07-25

On 2012-07-25 the FDA classified a Class II recall of MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras by Kimberly Clark, citing complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2017-2012
Classification	Class II
Status	terminated
Initiated	2009-09-17
Published	2012-07-25
Last updated	2026-09-13 11:53 UTC
Company	Kimberly Clark
Distribution	US

Product

MicroCool 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.

Reason

Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

Identifiers

code_info	Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Lar… Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx.

code_info

Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Lar…

Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2017-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.