WhichRecall
Class I — UrgentReported 2025-12-03

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Recalled by Glycar SA Pty., Ltd.

Reason for Recall

The impacted lot may not meet the required tensile strength specification.

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Recall Number
Z-0532-2026
Classification
Class I
Status
Ongoing
Category
device
Initiated
2025-10-09
Reported
2025-12-03
Distribution
US
Code Info
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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