POWERSEAL 5 mm — Class II medical device recall Z-1701-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-05-08, distributed nationwide. Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete
| Recall number | Z-1701-2024 |
|---|---|
| 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 | 2024-03-07 |
| Classified | 2024-04-30 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00821925044579 |
| Lot numbers | CA179370 |
| Model numbers | PS-0544CJDA |
Product
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0544CJDA
Reason for recall
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
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-1701-2024. 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.