Glycar SA Pty., Ltd.
Glycar SA Pty., Ltd. appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0532-2026, Class I) was initiated on October 9, 2025.
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0532-2026 | Class I | SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND IN | October 9, 2025 |
| Z-0531-2026 | Class I | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INT | October 9, 2025 |