Z-1886-2018 Class II Terminated
FDA device recall Z-1886-2018 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: 14873.
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
- 14873
Product Description
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
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 P4T745 P4T88Y P4T906 P4T91H P4TA60 P4TC8M P4TD0G P4TD2K R40015 R4011E R4025E R4035E R4042Z R4047X R4065E
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1886-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026