Glycar SA Pty., Ltd.: Medical Device Recall in 2025 - (Recall #: Z-0531-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Product Classification:

Class I

Date Initiated: October 9, 2025

Date Posted: December 3, 2025

Recall Number: Z-0531-2026

Event ID: 97877

Reason for Recall:

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

Status: Ongoing

Product Quantity: 30 units

Code Information:

UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated