FDA recall Z-0531-2026

Glycar SA Pty., Ltd. · Class I · device

Product

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Reason for recall

The impacted lot may not meet the required tensile strength specification.

Distribution

US

Key facts

Status: Ongoing
Initiation date: 2025-10-09
Report date: 2025-12-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irene, N/A, South Africa

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2026