FDAClass IIJuly 5, 2017

High Frequency Resection Electrodes recall

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in…

Why was High Frequency Resection Electrodes recalled?

Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: A22201C - Resection 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 Model: WA22037C - Resection electrode, loop style Lot # 16195P04L001, 16215P04L001, P16Y0001

Product
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in…
Recalling firm
Olympus Corporation of the Americas
Quantity
1264 units
Distribution
Nationwide Distribution
Recall date
July 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls