Ascent Healthcare Solutions, Inc. Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures.
Brand
Ascent Healthcare Solutions, Inc.
Lot Codes / Batch Numbers
Catalog No. 5329, Lot No 135736
Products Sold
Catalog No. 5329, Lot No 135736
Ascent Healthcare Solutions, Inc. is recalling Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile proced due to Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Recommended Action
Per FDA guidance
A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026