Recall Z-0485-2026— Covidien, LP
Class II · Ongoing
Class II FDA medical device recall by Covidien, LP, initiated 2025-09-25. It names 2 FDA 510(k) clearances: K222641, K191070. Product: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;. Reason: 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..
- Recalling firm
- Covidien, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-25
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
2 on FDA's record- K222641 — Signia Small Diameter Reloads Including Regular (Round) Tip Version
- K191070 — Signia Small Diameter Reloads
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.