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Glycar SA Pty., Ltd. FDA Recalls
2 recalls on file across devices, 2 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFClass IOct 9, 2025The impacted lot may not meet the required tensile strength |
| SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTClass IOct 9, 2025The impacted lot may not meet the required tensile strength |