FDAFDA · Food and drugs·Recall number Z-3213-2026
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Published September 23, 2026 · Recall initiated: July 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Transfemoral catheter, positing arm may detached due to weld issue.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PI CARDIA LTD
- Distributor
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Lot
- UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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