FDA Medical Device Recalls (openFDA)
Ethicon, Inc: VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.
- Recall number
- Z-0493-05
- Recalling firm
- Ethicon, Inc
- Product
- VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.
- Status
- Terminated
- Initiated
- 2004-12-16
- Posted
- 2005-02-02
- Terminated
- 2005-10-31
- Reason
- Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.
- Root cause
- Nonconforming Material/Component
- Action
- The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.
- Quantity
- 891electrodes
- Distribution
- Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distributors outside the US. The Foreign countries with accounts are: Austria, Czech Republic, Greece, Italy, Benelux, Poland, Portugal, Slovenia, Spain, Sweden, France, Germany, Ireland, U.K. Canada, China, Mexico, Taiwan, Venezuela, Korea, Australia, Brazil, and India.
- Lot, serial or model codes
- Product Code: 00480; Lot #s: 0404086, 0404121, 0404152, 0405010, 0405123, 0406014, 0406068, 0406130, 0407104, 0408031, 0409029, 0409080, 0410021, 0410103, 0411040.
- 510(k) numbers
- ["K962482"]
- PMA numbers
- not on file
- Product code
- HIH
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28