FDA Device recall Z-1889-2018
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST by Ethicon Endo Surgery, citing 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 introducin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1889-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-26 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Reason
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.
Identifiers
| code_info | Lots P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1889-2018%22
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