FDA Class II · Medical device · September 23, 2026
Pi-Cardia Inc recall — PI CARDIA LTD
Transfemoral catheter, positing arm may detached due to weld issue.
Official ID Z-3213-2026 · Official record ↗
PI CARDIA recalls
Recall found. PI CARDIA is named in FDA Class II recall Z-3213-2026 covering Pi-Cardia Inc. Hazard: Transfemoral catheter, positing arm may detached due to weld issue. Identifying details: 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.. Status: Ongoing.
Models with recalls
All PI CARDIA recalls
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.