CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report

MicroCool Breathable Impervious Gown recalled by Kimberly-Clark

Kimberly-Clark is recalling MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), distributed nationwide in the US. The recall was initiated on 17 Sep 2009 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 92354 (Secure-Fit Large), Lot #AH9141 and Product Code: 92355 (Secure Fit X-Large), Lot #AH9143. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number: 92354 (Large), Lot number range AH9072xxx to AH9175xxx; Product number: 92355 (X-Large), Lot number: AH9141 and Product number: 92358 (XX-Large), Lot number: AH9173.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2018-2012
FDA event ID: 62451
Recalling firm: Kimberly-Clark, Roswell, GA
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2009
FDA classified: 16 Jul 2012
Reported: 25 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Surgical Instruments

Timeline

17 Sep 2009	Recall initiated by company
16 Jul 2012	Classified by FDA	+1033 days
25 Jul 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), 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.

Where it was distributed

Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA

Nationwide Alabama Florida Georgia Kentucky Louisiana Mississippi North Carolina Ohio South Carolina Tennessee Virginia

Questions about this recall

Is MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large) recalled?

Yes. Kimberly-Clark recalled MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large) on 17 Sep 2009. The recall is Class II and its status is Terminated. Recall number Z-2018-2012.

Why was it recalled?

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

Which lots are affected?

Product Code: 92354 (Secure-Fit Large), Lot #AH9141 and Product Code: 92355 (Secure Fit X-Large), Lot #AH9143. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number: 92354 (Large), Lot number range AH9072xxx to AH9175xxx; Product number: 92355 (X-Large), Lot number: AH9141 and Product number: 92358 (XX-Large), Lot number: AH9173.

Where was it sold?

Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Kimberly-Clark

All 19

Reported	Class	Recall	Company	Reason	Where
14 Apr 2021Drug	CLASS II	Scott¿ Moisturizing Foam Hand Sanitizer recalled by Kimberly-Clark	Kimberly-Clark	Labeling Errors	Nationwide
23 Jan 2019Device	CLASS II	U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark	Kimberly-Clark	Other	Nationwide
23 Jan 2019Device	CLASS II	U by Kotex¿ Sleek¿, Regular/Super Tampons Multipack recalled	Kimberly-Clark	Other	Nationwide
23 Jan 2019Device	CLASS II	U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark	Kimberly-Clark	Other	Nationwide
23 Jan 2019Device	CLASS II	U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark	Kimberly-Clark	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide