Glycar SA Pty., Ltd. recalls SJM Pericardial Patch

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

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

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 Clearly label the identified stock as "WITHDRAWN PRODUCT" DO NOT DISTRIBUTE OR USE. 3.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 collection, return, or replacement of affected product as appropriate." For questions or require further clarification, contact: Malcolm Applewhite, malcolm@glycar.co.za On 10/17/2025, the firm issued an URGENT: MEDICAL DEVICE RECALL notice the medical facility via email. This notice explained the issue, potential risk to health, and requested the following: "Actions to be Taken by the Customer / User: 1. Identify and quarantine any affected products with lot number T2502257 in your possession. 2. Cease use of the affected device immediately. 3. Share this notice with applicable personnel within your institution. 4. Abbott will coordinate and arrange for return and replacement of affected units. 5. Complete and return the attached Acknowledgment Form within 5 business days to confirm receipt of this notice." For questions or assistance, contact: Regulatory Affairs Manager, Glycar SA (Pty) Ltd, Malcolm Applewhite, malcolm@glycar.co.za

• FDA enforcement recordOfficial FDA database entry for Z-0531-2026
• FDA 510(k) clearance · K963967The device's official FDA premarket clearance record
• FDA device classification · DXZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.3470The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Glycar SA Pty., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.