FDA Medical devices recall ·
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider… recall
- Recall number
- Z-3035-2026
- Date
- (initiated August 18, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 335 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Why was it recalled?
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
Distribution
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3035-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.