Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 12, 2013
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien LP recalled Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB… - a moderate-severity action.
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB… was recalled by Covidien LP in June 12, 2013. Reason: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patie…. Check the official notice for the remedy. Verify recall #Z-1468-2013 with the FDA Devices before acting.
The recall
Covidien LP issued this moderate-severity FDA Devices recall-Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patie….
- Moderate
- severity level
- 23K units
- affected scope
- Class II
- classification
- June 12, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1468-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1468-2013) was formally reported on June 12, 2013, with the manufacturer initiating the action on May 6, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien LP is listed as the recalling firm, operating out of North Haven, CT. Federal records list the affected scope as 23050 units.
The documented reason for this recall is: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Isra…. 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.
Medical Devices recalls over time
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.
Affected scope
23050 units
Related Recalls
6
3 from same agency
Product description
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Reason for recall
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1468-2013 |
| Date reported | June 12, 2013 |
| Date initiated | May 6, 2013 |
| Recalling firm | Covidien LP |
| Firm location | North Haven, CT |
| Affected scope | 23050 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Ku… |
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.
- Check the recall number (Z-1468-2013) 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? ▼
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.. Recalled by Covidien LP. Units affected: 23050 units.
Why was this product recalled? ▼
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1468-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1468-2013) 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.
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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 June 12, 2013. 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.