SJM Pericardial Patch — Class I medical device recall Z-0531-2026
Ongoing recall by Glycar SA Pty., Ltd., reported 2025-12-03. The impacted lot may not meet the required tensile strength specification.
| Recall number | Z-0531-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glycar SA Pty., Ltd., Irene, N/A, South Africa |
| Recall initiated | 2025-10-09 |
| Classified | 2025-11-25 |
| Reported by FDA | 2025-12-03 |
| Quantity | 30 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05414734007276 |
| Lot numbers | 2028.04.11, 20280128, T2502257, T2505144 |
| Model numbers | C0914 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0531-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.