Z-0736-05

FlexTrayTM Endopath GYN Tray, Kit code KD005

Name: Z-0736-05 FlexTrayTM Endopath GYN Tray, Kit code KD005
Creator: Ethicon Endo-Surgery
Published: 2004-12-15
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2004-12-15 / Terminated

FDA source

Ethicon Endo-Surgery began a recall of FlexTrayTM Endopath GYN Tray, Kit code KD005 on 2004-12-15. The reason FDA records is "Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0736-05
Status: Terminated
Initiated: 2004-12-15
Posted: 2005-04-27
Terminated: 2012-05-30
Recalling firm: Ethicon Endo-Surgery Inc
Product: FlexTrayTM Endopath GYN Tray, Kit code KD005.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
FDA root cause: Other
Action: The recalling firm sent letters to hospitals and distributors, dated 12/14/04.
Quantity in commerce: 234 devices.
Distribution: The devices were distributed to hospitals and distributors located throughout the United States and to foreign consignees located in Saudi Arabia, Austria, Egypt, United Kingdom, Germany, France, Lebanon, The Netherlands, Spain, Pakistan, South Africa, Italy, United Arab Emirate, Czech Republic, Sweden, Switzerland, Greece, India, Portugal, Slovenia, Hungary, Palestine, and Kuwait.
Product codes and lots: V4290J, V42NOT, V4355L, V41W98.

Product code MDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)