← FDA ENFORCEMENT
Z-0532-2026Class I
Glycar SA Pty., Ltd.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Glycar SA Pty., Ltd.
Product type
Device
Status
Ongoing
Report date
2025-12-03
Distribution
US
Firm state
N/A
Product quantity
18 units
Initiated by
Voluntary: Firm initiated
Reason for recall
The impacted lot may not meet the required tensile strength specification.
Product description
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Code / lot info
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →