- Recalling firm
- PFM MEDICAL INC.
- Reason for recall
- A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
- Affected products (lot / model / serial)
- REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
- Units affected
- 32
- Distribution pattern
- US Nationwide distribution in the states of NY, MD.
- Firm location
- Carlsbad, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2526-2026
- Recall initiated
- April 21, 2026
- FDA classification date
- June 23, 2026
- FDA report date
- July 1, 2026
- FDA event ID
- 98942
- Last updated on HTM Vibe
- July 23, 2026