Olympus Corporation Of The Americas: Electrosurgical, Cutting & Coagulation & Accessories
Recall Summary Olympus Corporation of the Americas is recalling POWERSEAL 5 MM Curved Jaw Sealer & Divider devices because some outer packaging is labeled incorrectly as a 37-cm device when it should be labeled as 23-cm. The affected devices were distributed nationwide in the US, as well as in Australia, European Union, and Japan.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
- Reason
- Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-18
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b8bac1f6-137e-43e1-8729-916e1fb37a34