POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting
Summary
The FDA issued a Class II for POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double A by Olympus Corporation of the Americas. Reason: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device..
Details
Source
Device Recall
External ID
Z-3035-2026
Action Date
2026-09-02
Status
Ongoing
Category
device
Product Description
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Lot/Code Info: Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
Quantity Affected: 335 units
Reason for Recall
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Distribution
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-18
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Olympus Corporation of the Americas has 333 FDA actions in our database, including 333 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 333 FDA actions in our database, including 333 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3035-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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