5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
Reported: May 23, 2018 Initiated: March 26, 2018 #Z-1887-2018
Product Description
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
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.
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 1500
- Distribution
- Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT. Recalled by Ethicon Endo-Surgery Inc. Units affected: 1500.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1887-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11