Z-0916-06

Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01

Name: Z-0916-06 Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01
Creator: Ethicon Endo-Surgery Inc
Published: 2006-04-20
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2006-04-20 / Terminated / root cause: packaging

FDA source

Ethicon Endo-Surgery Inc began a recall of Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01 on 2006-04-20. The reason FDA records is "There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device". 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-0916-06
Status: Terminated
Initiated: 2006-04-20
Posted: 2006-05-31
Terminated: 2012-09-26
Recalling firm: Ethicon Endo-Surgery Inc
Product: Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
Root cause tag: packaging
FDA 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 in commerce: 168 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.
Product codes and lots: Lot C4DG34 and C4DN1J.

Product code GCJ

K912492Class IIEvacuation/irrigation/elecrosurgical DeviceETHICON, Inc. / cleared 1991-10-21

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)