FDAOctober 9, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

glycar sa ptyglycarglycar sa

UPCs

05414734007269

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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