Z-2526-2026 Class II Ongoing
FDA device recall Z-2526-2026 was initiated by PFM MEDICAL INC. on April 21, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- April 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
Product Description
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
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.
Distribution Pattern
US Nationwide distribution in the states of NY, MD.
Code Information
REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)