Reported Oct 5, 2022 · Ongoing
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
Olympus POWERSEAL 5MM23CMCURVED JAW SEALER & DIVIDER
- DOUBLE-ACTION Model NumberPS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures
- Lot codes and dates
- UDI-DI00821925044531
- Lot NumbersCA191167 CA191168 CA191169 CA191170
- Amount recalled
- 27 units (5/box) US; 83 units(5/box) OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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