FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02.
- Recall number
- Z-0917-06
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02.
- Status
- Terminated
- Initiated
- 2006-04-20
- Posted
- 2006-05-31
- Terminated
- 2012-09-26
- Reason
- There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Root cause
- Packaging process control
- Action
- The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
- Quantity
- 186 cases/6 devices per case.
- Distribution
- The recalled product was distributed throughout the United States and to foreign consignees including Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela.
- Lot, serial or model codes
- Lot C4DG7H and C4DL5W.
- 510(k) numbers
- ["K912492"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 1527736
- Firm city
- Cincinnati
- Firm state
- OH
- 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