Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206
Brand
Davol, Inc., Sub. C. R. Bard, Inc.
Lot Codes / Batch Numbers
Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005. If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.
Products Sold
Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005. If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.
Davol, Inc., Sub. C. R. Bard, Inc. is recalling Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206 due to Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula
Recommended Action
Per FDA guidance
Davol Inc. notified US Customers by letter on 12/27/05 via Federal Express. Bard Regulatory International was notified 12/22/05 to recall to accounts outside the US. Accounts are requested to return recalled product. A second letter issued dated January 5, 2006 to include additional product codes not identified in the first letter, specifically to the accounts that received those lots. On 3/24 / 06, Davol issued a third Recall Notification for the extended recall to Hospitals and Distributors and a Dear Doctor Letter to Chief of Surgery.
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