CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
Signia" Small Diameter Curved Tip Intelligent Reload Vascular/Thin) recalled
Covidien is recalling Signia" Small Diameter Curved Tip Intelligent Reload Vascular/Thin), distributed nationwide in the US. The recall was initiated on 25 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0486-2026
- FDA event ID
- 97792
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2025
- FDA classified
- 7 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 25 Sep 2025 | Recall initiated by company | |
| 7 Nov 2025 | Classified by FDA | +43 days |
| 19 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Product as listed by the FDA
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
Questions about this recall
Why was it recalled?
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Which lots are affected?
CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Signia" Small Diameter Curved Tip Intelligent Reload Vascular/Thin) recalled | Covidien | Other | Nationwide |
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