FDAFDA recall Z-2526-2026 · Jul 1, 2026
PFM MEDICAL INC.: Multi-Snare Set: 5 mm x 125 cm recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
- Quantity
- 32
- Distribution
- US Nationwide distribution in the states of NY, MD.
- Recalling firm
- PFM MEDICAL INC., Carlsbad, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-21
Source: openFDA enforcement record Z-2526-2026 · search recall number Z-2526-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.