FDA Medical devices recall ·
Multi-Snare Set: 5 mm x 125 cm recall
- Recall number
- Z-2526-2026
- Date
- (initiated April 21, 2026)
- Company / brand
- Pfm Medical Inc.
1916 Palomar Oaks Way, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Why was it recalled?
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.
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
REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
Distribution
US Nationwide distribution in the states of NY, MD.
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-2526-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.