Kimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure
Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (sterile medical device) where the failure of the seal could lead to infection, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Kimberly-Clark Corporation is recalling 89,856 units of ULTRA Fabric Reinforced surgical Gowns, size X-Large, sterile. The product is a sterile, single-use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The recall was initiated because the package seam of some units may not remain properly sealed, which means the contents might not be sterile as labeled. The affected product code is 95221, and the recall includes all lot numbers beginning with AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, and AH2006*** to AH2146***.
The product was distributed nationwide. Consumers and healthcare facilities should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the recalling firm, Kimberly-Clark Corporation.
The recalled product
- Product
- ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
- Manufacturer
- Kimberly-Clark Corporation
- Category
- Medical Device — Surgical Gowns
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 (4)
- Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***
- AH0007*** to AH0356***
- AH1008 *** to AH1364***
- AH2006*** to AH2146***
Distribution
Distributed nationwide across the United States.
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.
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