FDA Medical devices recall ·
Pi-Cardia Inc recall
- Recall number
- Z-3213-2026
- Date
- (initiated July 6, 2026)
- Company / brand
- Pi Cardia Ltd
5, David Pikes St, Rehovot, N/A, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 46 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Why was it recalled?
Transfemoral catheter, positing arm may detached due to weld issue.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
States: California Delaware Kansas Massachusetts New Hampshire New York Pennsylvania Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3213-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.