Z-1889-2018 Class II Terminated
FDA device recall Z-1889-2018 was initiated by Ethicon Endo-Surgery Inc on Mar 26, 2018 and is designated Class II. Reason for recall: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle… The recall status is terminated (terminated Apr 8, 2020). Affected quantity: 11074.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- Mar 26, 2018
- Termination Date
- Apr 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11074
Product Description
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Reason for Recall
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Distribution Pattern
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
Code Information
Lots P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1889-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026