Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
Brand
Ansell Healthcare Products LLC
Lot Codes / Batch Numbers
Lot Number 0810015305.
Products Sold
Lot Number 0810015305.
Ansell Healthcare Products LLC is recalling Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Ste due to Premature degradation which could result in tearing during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Premature degradation which could result in tearing during use.
Recommended Action
Per FDA guidance
The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC representative.
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