Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template.
Brand
Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa
Lot Codes / Batch Numbers
Lot Number / Expiration Date:1001381/2008-08 UPC Codes:C8004 +H699C80040K
Products Sold
Lot Number / Expiration Date:1001381/2008-08 UPC Codes:C8004 +H699C80040K
Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa is recalling The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard W due to The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retract. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit.
Recommended Action
Per FDA guidance
The recall was initiated on October 14,2005. Applied Medical will contact all customers involved in the recall via overnight FEDEX / UPS. A follow-up communication concerning the recall notification letter will be sent to each of the customers who have not responded with 30 days.Applied is requesting product lot listed in the notification be returned to Applied Medical. All product involved in the recall will be destroyed.
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