Class I — Glycar SA Pty., Ltd.
| Recalling firm | GLYCAR S.A |
|---|---|
| Registered facility | GLYCAR SA PTY., LTD. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | The impacted lot may not meet the required tensile strength specification. |
| Product | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Quantity | 30 units |
| Distribution | US |
| Initiated | 2025-10-09 |
| Classified | 2025-11-25 |
| Recall number | Z-0531-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Glycar SA Pty., Ltd. (Z-0531-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97877/
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