VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect
Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a manufacturing defect resulting in a potential internal metal burr. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported score High (3).
Plain-English summary
Covidien LP is recalling the VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS). The recall was initiated due to a manufacturing non-conformance that may result in a metal shaving or burr on the inside of the cannula where the Cannula and Body components are welded together.
No illnesses or injuries have been reported in connection with this defect. The recall affects 51 units with specific serial numbers distributed worldwide, including in North Carolina and Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, and Sweden.
The device is identified by UDI-DI: 10884521784048. Healthcare providers and facilities should verify their inventory against the recalled serial numbers provided in the FDA recall notice.
The recalled product
- Product
- VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
- Manufacturer
- Covidien LP
- Affected units
- 51
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 (1)
- UDI-DI: 10884521784048
Distribution
Part of a larger recall action
This product is one of 3 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 3 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 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
Same hazard · metal burr
See all →- HighBiomet Compress Device Anchor Plug Recall - Metal Burrs May Extend Surgery
FDA (Devices) · 2023-11-29
- HighBiomet Compress Device Anchor Plugs recalled for metal burrs in transverse holes
FDA (Devices) · 2023-11-29
- HighBiomet Compress Device Short Anchor Plug recalled for metal burrs
FDA (Devices) · 2023-11-29
- HighSurgical implant anchor plugs may contain metal burrs affecting insertion
FDA (Devices) · 2023-11-29
- HighBiomet Compress Anchor Plugs Recalled for Metal Burrs in Transverse Holes
FDA (Devices) · 2023-11-29