The Recall Desk
HighFDA (Devices)·Z-2017-2012·Announced 2012-07-25

Kimberly-Clark Recalls MicroCool Surgical Gowns Due to Material Defects

Kimberly-Clark is recalling specific lots of MicroCool surgical gowns because they pill, lint, or allow blood strikethrough, potentially compromising sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (surgical gown) where the defect (blood strikethrough) implies a breach of sterility, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for theoretical or unreported harm.

Plain-English summary

Kimberly-Clark Corporation is recalling 79,941 units of MicroCool Breathable Impervious Surgical Gowns in Large and X-Large sizes. The affected products are sterile, single-use surgical apparel intended to protect patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate matter. The gowns were manufactured in Honduras and distributed nationwide, including in Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Ohio, South Carolina, Tennessee, and Virginia.

The recall was initiated after complaints were received regarding the gowns pilling or balling, linting, and abrading. Additionally, reports indicated blood strikethrough and fibers falling off the gowns. These defects may compromise the integrity of the barrier, potentially exposing patients and healthcare workers to microorganisms or body fluids.

The recall includes specific product codes and lot numbers for Large, X-Large, XX-Large, and Specialty sizes. Customers were notified to include lot ranges from AH9076xxx to AH9175xxx, with specific lot numbers listed for each product code. Healthcare facilities should stop using the affected gowns and contact Kimberly-Clark for instructions on return or disposal.

The recalled product

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 wor
Manufacturer
Kimberly-Clark Corporation
Category
Medical Device — Surgical Apparel
Hazard
Affected units
79,941

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • Lot numbers: AH9072

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Kimberly-Clark Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Kimberly-Clark Corporation

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Same hazard · material defect

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