5mm Endopath Xcel with Optiview Technology — Class II medical device recall Z-1887-2018
Terminated recall by Ethicon Endo-Surgery Inc, reported 2018-05-23, distributed nationwide. Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, i
| Recall number | Z-1887-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2018-03-26 |
| Classified | 2018-05-15 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2020-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BE, CA, CL, JP, KR, MX, SA, SG, TW |
| Quantity | 1,500 |
| Reason classes | packaging |
| Lot numbers | P4TD1E, R4001U, R4052P |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1887-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.