FDAFDA recall Z-3035-2026 · Sep 2, 2026
Olympus Corporation of the Americas: POWERSEAL 5 MM (in diameter) 23 CM (long) recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- Quantity
- 335 units
- Distribution
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-18
Source: openFDA enforcement record Z-3035-2026 · search recall number Z-3035-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.