Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204
Brand
Davol, Inc., Sub. C. R. Bard, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****
Products Sold
Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****
Davol, Inc., Sub. C. R. Bard, Inc. is recalling Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204 due to Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06). 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. (Extension of recall Z-0524/0526-06)
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