CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Endopath Xcel with Optiview Technology recalled by Ethicon Endo-Surgery
Ethicon Endo-Surgery is recalling Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve shaft, distributed nationwide in the US. The recall was initiated on 26 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1889-2018
- FDA event ID
- 79801
- Recalling firm
- Ethicon Endo-Surgery, Blue Ash, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2018
- FDA classified
- 15 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 26 Mar 2018 | Recall initiated by company | |
| 15 May 2018 | Classified by FDA | +50 days |
| 23 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Where it was distributed
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
Questions about this recall
Is Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve shaft recalled?
Yes. Ethicon Endo-Surgery recalled Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve shaft on 26 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1889-2018.
Why was it 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 lots are affected?
Lots P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642
Where was it sold?
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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