Recall Z-0532-2026— Glycar SA Pty., Ltd.

Name: FDA recall Z-0532-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-09

Class I · Ongoing

Class I FDA medical device recall by Glycar SA Pty., Ltd., initiated 2025-10-09. It names one FDA 510(k) clearance: K963967. Product: SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE. Reason: The impacted lot may not meet the required tensile strength specification..

Recalling firm: Glycar SA Pty., Ltd.
Classification: Class I
Status: Ongoing
Initiated: 2025-10-09
Firm location: Irene, N/A, South Africa

510(k) clearances named in this recall

1 on FDA's record

K963967 — GLYCAR PERICARDIAL PATCHGlycar, Inc.·cleared 1997-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.