POWERSEAL 5 MM — Class II medical device recall Z-3035-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-09-02, distributed nationwide. Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
| Recall number | Z-3035-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2026-08-18 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, JP |
| Quantity | 335 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00821925044531 |
| Lot numbers | FR490902 |
| Model numbers | PS-0523CJDA |
Product
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Reason for recall
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3035-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.