FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter 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, and the hazard involves a component entering the patient's cavity, which constitutes a significant injury risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Versaport Bladeless Optical Fixation Cannula - 5mm (Product Code: ONBFCA5ST) manufactured by Covidien LP. The recall involves 57,461 units distributed worldwide, including the United States and various international markets. The specific lot numbers affected range from N2J0150X through N3C0683X, with the exception of specific lots identified as acceptable for use.
The recall is being conducted because seals on the cannula may disengage. This failure may result in a component inadvertently disengaging and entering the patient's cavity during gynecologic, general, thoracic, or urologic endoscopic procedures. The product is intended to create and maintain a port of entry for these medical procedures.
Healthcare providers and facilities should stop using the affected units and contact the recalling firm for instructions on how to return or dispose of the product. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST 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
- 57,461
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 →Related recalls
Same manufacturer · Covidien LP
See all →- SevereSurgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
Same hazard · component disengagement
See all →- HighRecall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector
FDA (Devices) · 2017-07-05
- SevereFDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
FDA (Devices) · 2013-06-12
- SevereFDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
FDA (Devices) · 2013-06-12
- SevereFDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
FDA (Devices) · 2013-06-12
- HighFDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement
FDA (Devices) · 2013-06-12