Z-1700-2024 Class II Ongoing
FDA device recall Z-1700-2024 was initiated by Olympus Corporation Of The Americas on Mar 7, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 850 units: (400 units US);(450 units OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Mar 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 850 units: (400 units US);(450 units OUS)
Product Description
POWERSEAL 5 mm, 37 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-0537CJDA
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
Code Information
UDI-DI: 00821925044555 Lot numbers: CA182543, CA182544, CA182546, CA182548, CA191230
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1700-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026