# FDA recall Z-0532-2026

> **Glycar SA Pty., Ltd.** · Class I · device recall initiated 2025-10-09.

## Product

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.

## Distribution

US

## Key facts

- **Recall number:** Z-0532-2026
- **Recalling firm:** Glycar SA Pty., Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-09
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irene, N/A, South Africa

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2026

## Citation

> AI Analytics. FDA recall Z-0532-2026. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-0532-2026. Source: US FDA. Licensed CC0.

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