Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202
Brand
Davol, Inc., Sub. C. R. Bard, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Recalled Lot Numbers: 43AOD 43LOD 43BOD 43APD 43COD 43BPD 43DOD 43CPD 43EOD 43DPD 43FOD 43EPD 43GOD 43FPD 43HOD 43GPD 43IOD 43HPD 43JOD 43IPD 43KOD; Market Wthdrawal Lot Numbers: 43JPD 43DQD 43KPD 43EQD 43LPD 43FQD 43AQD 43GQD 43BQD 43HQD 43CQD 43IQD* *Redesigned products will be clearly indicated on the label. Any product of this lot with the word 'Redesigned' on the label is not part of this Market Withdrawal.
Davol, Inc., Sub. C. R. Bard, Inc. is recalling Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202 due to PET recoil ring breakage-Memory recoil ring may break which could 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
PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
Recommended Action
Per FDA guidance
Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.
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