Recall of Versaport Bladeless Optical Trocar Due to Seal Disengagement
FDA Class II recall of 126,925 Versaport trocars because seals may disengage, risking component entry into the patient's cavity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential for serious injury (component entering patient cavity) are rated as Severe (4), as they are not Class I but involve significant risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm (Product Code: ONB5STF) manufactured by Covidien LP. The recall involves 126,925 units distributed nationwide in the United States and internationally to multiple countries including Canada, the United Kingdom, Germany, and Japan.
The recall is being conducted because seals on the device may disengage from the cannula. This failure may result in a component inadvertently disengaging into the patient's cavity during gynecologic, general, thoracic, or urologic endoscopic procedures. The affected lot numbers range from N2H0353X through N3D0033X, with specific exceptions noted in the source text that are acceptable for use.
Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF 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.
- Manufacturer
- Covidien LP
- Affected units
- 126,925
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- N2H0166X
- N2H0286X
- N2H0357X
- N2 H051 6UX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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