Glycar SA Pty., Ltd. recalls SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTF…
- Recall date
- October 9, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0531-2026
- FDA classification
- Class I
- Brand / firm
- Glycar SA Pty., Ltd.
- Sold / distributed
- US
Why it was recalled
The impacted lot may not meet the required tensile strength specification.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
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