Recall Z-0531-2026 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Glycar SA Pty., Ltd.
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
| Date | Nov 25, 2025 (initiated Oct 9, 2025) |
| Status | Open, Classified |
| Reason | The impacted lot may not meet the required tensile strength specification. |
| Root cause | Process control |
| Action | Glycar issued a Stock Withdrawal Notification to its sole distributor on 10/09/2025. The notice explained the issue and requested the following: "Required Actions 1. Immediately identify and segregate all affected stock in your possession. 2. Clearly label the identified stock as "WITHDRAWN PRODUCT" DO NOT DISTRIBUTE OR USE. 3. Suspend any further distribution or transfer of the affected lots. 4. Provide written confirmation of the quantity and storage location of all affected stock within five (5) business days of receipt of this notification. 5. Our Quality team will coordinate co |
| Quantity | 30 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963967 | GLYCAR PERICARDIAL PATCH Glycar, Inc., Oct 31, 1997 |