FDA Device recall Z-3035-2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action by Olympus, citing potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3035-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-18 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Reason
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Identifiers
| code_info | Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3035-2026%22
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