FDA Device Recall Z-0532-2026

Glycar SA Pty., Ltd. · Irene, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Lot / serial / GTIN: UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25

Quantity: 18 units

Reason for recall

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

Recall record

Recall number: Z-0532-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US
Recall initiated: 2025-10-09
Classified by FDA Center: 2025-11-25
FDA published: 2025-12-03
Recalling firm: Glycar SA Pty., Ltd.
Firm location: Irene, N/A, South Africa

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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