Z-2629-2017Class II

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for...

Name: Z-2629-2017 High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for...
Creator: Olympus Corporation of the Americas
Published: 2017-04-19
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2017-04-19 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and... on 2017-04-19. FDA classified it as Class II and gives the reason as "Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2629-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-19
Posted: 2017-06-26
Terminated: 2018-10-01
Recalling firm: OLYMPUS Corporation of the Americas
Product: High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Product code: GCP Endoscope, Ac-Powered And Accessories
Reason for recall: Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
FDA root cause: Under Investigation by firm
Action: Olympus sent an Urgent Medical Device Removal Notice dated April 26, 2017, to affected customers to inform them of the issue. The notice identified the issue, the actions to be taken by the end user. It advised that customers discontinue use of any affected electrodes if found, contact Olympus Customer Care Center and they will provide instructions on how to return the affected product as well get a free replacement. Customer were instructed fax the completed reply from to 484-896-7128. Customer with questions should call 484-896-5688. For questions regarding this recall call 484-896-5000.
Quantity in commerce: 1264 units
Distribution: Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2629-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2629-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-26

Product code GCP

K790071Class IIEndoscope and AccessoriesOlympus Corp. / cleared 1979-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)