PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported May 23, 2018

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT

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…

Recall #
Z-1885-2018
Affected scope
118352
Initiated
March 26, 2018
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Ethicon Endo-Surgery Inc recalled 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, … — a moderate-severity action.

5mm Endopath Xcel with Optiview Technology, Bladeless 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-1885-2018 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, ….

Moderate
severity level
118K units
affected scope
Class II
classification
May 23, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1885-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1885-2018) 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 118352, a scale large enough to require multi-state distribution tracking.

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, 6 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.

Medical Devices recalls over time

Where this recall sits in its category — 40,409 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,243

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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

118352

Related Recalls

6

6 from same agency

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1885-2018
Date reported May 23, 2018
Date initiated March 26, 2018
Recalling firm Ethicon Endo-Surgery Inc
Firm location Blue Ash, OH
Affected scope 118352
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.

Scale of Impact

118352 units affected — multi-state distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1885-2018) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting — recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

Frequently Asked Questions

What product was recalled?
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT. Recalled by Ethicon Endo-Surgery Inc. Units affected: 118352.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1885-2018.
Where was the recalled product distributed?
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..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1885-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 23, 2018.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.