Z-3102-2011

OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in...

Name: Z-3102-2011 OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in...
Creator: Olympus America Inc.
Published: 2010-12-22
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2010-12-22 / Terminated / root cause: packaging

FDA source

Olympus America Inc. began a recall of OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection... on 2010-12-22. The reason FDA records is "The device sterile package seal shows evidence of being breached or was breached". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3102-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-08-31
Terminated: 2012-09-28
Recalling firm: OLYMPUS Corporation of the Americas
Product: OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.
Product code: EZO Urethrotome
Reason for recall: The device sterile package seal shows evidence of being breached or was breached
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Olympus America Inc. sent an "URGENT PRODUCT RECALL" letter dated December 22, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to destroy or discard, if found. A questionnaire was attached to the letter for customers to complete and return via fax to Olympus at 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this recall.
Quantity in commerce: 1305 devices
Distribution: USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OR, TX, VA, VT, and WI.
Product codes and lots: All lot numbers of Pediatric knives: Model numbers A37008A, A37009A, A37010A and Pediatric HF resection electrodes: Model numbers A37011A, A37012A, A37013A.

Product code EZO

K904939Class IIFlexible and Rigid Ureterotome SystemOlympus Corp. / cleared 1992-01-07

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)