Glycar SA Pty., Ltd.: Device Recall
Recall #Z-0532-2026 · 10/09/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-0532-2026
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Glycar SA Pty., Ltd.
- Status
- Ongoing
- Date Initiated
- 10/09/2025
- Location
- Irene, N/A, South Africa
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Reason for Recall
The impacted lot may not meet the required tensile strength specification.
Product Description
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Distribution Pattern
US
Other Recalls by Glycar SA Pty., Ltd.
- Class I: Dangerous 10/09/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.