Glycar SA Pty., Ltd. recalls SJM Pericardial Patch
- Recalling company
- Glycar SA Pty., Ltd.
- Product
- SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- Reason
- The impacted lot may not meet the required tensile strength specification.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Oct 9, 2025
- Reported
- Dec 3, 2025
- Distribution
- US
- Status
- Ongoing
- Quantity
- 30 units
- Lot / codes
- UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
- Company location
- Irene, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0531-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0531-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.