FDA Device recall Z-1701-2024
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties a…
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties a… by Olympus, citing 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 scree….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1701-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-07 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI:00821925044579 Lot Code: CA179370 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1701-2024%22
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