Cordis US Corp Recalls
5 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (5)
- Class II
March 4, 2025
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
product mix-up; Vascular stent labeled as one size but contains a different size.
- Class II
March 4, 2025
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
product mix-up; Vascular stent labeled as one size but contains a different size.
- Class II
February 7, 2025
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary o
Catheter manufactured at the incorrect length.
- Class II
November 28, 2023
MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
- Class II
November 28, 2023
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
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