Class II — PFM MEDICAL INC.
| Recalling firm | PFM Medical |
|---|---|
| Registered facility | pfm medical cpp SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 |
| Quantity | 32 |
| Distribution | US Nationwide distribution in the states of NY, MD. |
| Initiated | 2026-04-21 |
| Classified | 2026-06-23 |
| Recall number | Z-2526-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PFM MEDICAL INC. (Z-2526-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98942/
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