Recall archive / FDA device enforcement
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, P... — FDA record Z-0531-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 9, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Glycar SA Pty., Ltd.
- Quantity
- 30 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0531-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 3, 2025
- Recall initiation date
- Oct 9, 2025
- Center classification date
- Nov 25, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.