FDA Device recall Z-0531-2026
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914
- FDA Device
- Class I
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class I recall of SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914 by Glycar, citing the impacted lot may not meet the required tensile strength specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0531-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-10-09 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Glycar |
| Distribution | n/a |
Product
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Reason
The impacted lot may not meet the required tensile strength specification.
Identifiers
| code_info | UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2026%22
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