CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report
Multi-Snare Set recalled by Pfm Medical
PFM Medical is recalling Multi-Snare Set, distributed nationwide in the US. The recall was initiated on 21 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2526-2026
- FDA event ID
- 98942
- Recalling firm
- PFM Medical, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2026
- FDA classified
- 23 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Apr 2026 | Recall initiated by company | |
| 23 Jun 2026 | Classified by FDA | +63 days |
| 1 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Where it was distributed
US Nationwide distribution in the states of NY, MD.
Questions about this recall
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.
Which lots are affected?
REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
Where was it sold?
US Nationwide distribution in the states of NY, MD.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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