Class I
Medical Device Recall: SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Glycar SA Pty., Ltd. · October 9, 2025
Reason for Recall
The impacted lot may not meet the required tensile strength specification.
Distribution
US
Quantity Affected
30 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0531-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.