Agency classClass IIOur severity:Severe FDA (Devices)·Z-1469-2013·Announced 2013-06-12

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Medical Device — Surgical Instruments
Hazard: component-disengagement
foreign-body
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.

See all 6 products in this recall →

Same manufacturer · Covidien LP

See all →

Severe
Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
Severe
Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
High
V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
High
Surgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
High
V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19

Same hazard · component disengagement