Molnlycke Health Care, Inc Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia
Brand
Molnlycke Health Care, Inc
Lot Codes / Batch Numbers
Lot #07B026, Size 8
Products Sold
Lot #07B026, Size 8
Molnlycke Health Care, Inc is recalling Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia due to Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.
Recommended Action
Per FDA guidance
Consignees were notified by registered mail on 07/23/2007. The notice contained a Recall Response Form to confirm receipt of the notice and to verify if the product is still in inventory. The notice instructed to consignee to inspect their inventory for Biogel Skinsense Polyisoprene Surgical Gove, lot #07B026, Size 8. If this lot and size are in their inventory, they were instructed to discontinue use, quarantine the product and return the product to Molnlycke Healthcare.
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