VERSAPOINT, Hysteroscopic system Connector Cable… recallZ-0493-05 · Ethicon, Inc · initiated Dec 16, 2004
Terminated All recalls posted in February 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.
Recall details
- Recall number
- Z-0493-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 16, 2004
- Posted by the FDA
- Feb 2, 2005
- Recalling firm
- Ethicon, Inc
- Quantity
- 891electrodes
- Product code
- HIH
- FDA submissions
- K962482
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Product Code: 00480; Lot #s: 0404086, 0404121, 0404152, 0405010, 0405123, 0406014, 0406068, 0406130, 0407104, 0408031, 0409029, 0409080, 0410021, 0410103, 0411040.
Other devices under the same FDA submission
3 devices cleared under K962482 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GYNECARE VERSAPOINT 00467Ethicon Inc. · HYSTEROSCOPE (AND ACCESSORIES)5 reports
- GYNECARE VERSAPOINT 00468Ethicon Inc. · HYSTEROSCOPE (AND ACCESSORIES)4 reports
- GYNECARE VERSAPOINT 00466Ethicon Inc. · HYSTEROSCOPE (AND ACCESSORIES)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page