Reported Dec 3, 2025 · Ongoing
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP,…
Glycar SA Pty., Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glycar SA Pty., Ltd. · 1 Albert Road · Irene, N/A · N/A
Is this the product you have?
- SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- Lot codes and dates
- UDI/DI 05414734007276
- Lot Numbers
T2502257exp. 20280128T2505144exp. 2028.04.11
- Amount recalled
- 30 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
The impacted lot may not meet the required tensile strength specification.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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