SJM Pericardial Patch recall
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Why was SJM Pericardial Patch recalled?
The impacted lot may not meet the required tensile strength specification.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
- Product
- SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- Recalling firm
- Glycar SA Pty., Ltd.
- Quantity
- 18 units
- Distribution
- US
- Recall date
- December 3, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)