Device recall
Z-0531-2026: SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914…
FDA device recall · Class I · Glycar SA Pty., Ltd.
Key facts
| Recall number (Z-number) | Z-0531-2026 |
|---|---|
| Recall event | 97877 |
| Product | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product code | DXZ |
| Recalling firm | Glycar SA Pty., Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K963967 |
| FEI number | 3002807088 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database