Irene, N/A, South Africa
Glycar SA Pty., Ltd. recalls
1 recall recorded since 2018, most recently on 9 October 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 9 October 2025
- Reason
- The impacted lot may not meet the required tensile strength specification.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0532-2026, Z-0531-2026
- SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.