Z-1885-2018 Class II Terminated
FDA device recall Z-1885-2018 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: 118352.
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
- 118352
Product Description
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
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 P4T58Y P4T59E P4T627 P4T665 P4T66C P4T716 P4T71L P4T780 P4T83K P4T844 P4T87R P4T88E P4T88G P4T88H P4T927 P4T942 P4T946 P4T94D P4TA19 P4TA3V P4TA4N P4TA4R P4TA9K P4TA9R P4TC2E P4TC2T P4TC67 P4TC6Z P4TD1M R4000W R40045 R4004G R4007H R4013R R40172 R4017C R4021R R4021U R4023D R40267 R4026E R4031V R4036K R4036V R40397 R4041C R4041J R4044A R4044K R4048E
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1885-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026