Reported Jul 5, 2017 · Terminated
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic…
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 · 18034-0610
Is this the product you have?
- High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published A22201CResection electrode, loop style — Lot # 16123P03L001, 16124P03L001, 16131P03L001, 16139P03L001, 16140P03L001, 16144P03L001, 16144P03L002, 16144P03L003, 16155P03L001, 16169P03L001,16173P03L001, 16174P03L001 16174P03L002, 16223P03L001,16224P03L001,16236P03L001 P16X0001, P16X0002,P16X0003,P16X0004,P16Y0001,P16Y0002 P16Y0003,P16Y0004,P16Y0005,P16Y0006,P16Y0007,P16z0001 P16Z0002,P16Z0003,P1710001,P1720001,P1720002 WA22037CResection electrode, loop style — Lot # 16195P04L001, 16215P04L001, P16Y0001 - Amount recalled
- 1264 units
Where it was sold
- Nationwide
Why it was recalled
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
This product could cause temporary or reversible health problems — stop using it.
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