Severity
Moderate
FDA Devices recall · Reported May 23, 2018
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…
Ethicon Endo-Surgery Inc recalled 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, … - a moderate-severity action.
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, … was recalled by Ethicon Endo-Surgery Inc in May 23, 2018. Reason: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, …. Check the official notice for the remedy. Verify recall #Z-1888-2018 with the FDA Devices before acting.
The recall
Ethicon Endo-Surgery Inc issued this moderate-severity FDA Devices recall-Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1888-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1888-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on March 26, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Ethicon Endo-Surgery Inc is listed as the recalling firm, operating out of Blue Ash, OH. Federal records list the affected scope as 95233.
The documented reason for this recall is: 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 insertio… Distribution data in the federal record shows the product reached: Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
95233
Related Recalls
6
3 from same agency
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1888-2018 |
| Date reported | May 23, 2018 |
| Date initiated | March 26, 2018 |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Firm location | Blue Ash, OH |
| Affected scope | 95233 |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 23, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.