⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Glycar SA Pty., Ltd.: SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Medical DevicesSource: FDA (device) · Date: 2025-12-03

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Glycar SA Pty., Ltd.
Product
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Reason / hazard
The impacted lot may not meet the required tensile strength specification.
Classification
Class I
Status
Ongoing
Distribution / sold at
US
Recall initiated
2025-10-09
Code info
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Product quantity
18 units
Voluntary mandated
Voluntary: Firm initiated
City
Irene
State
N/A
Country
South Africa
Event id
97877
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