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

Lot, batch or date codesREF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
Quantity recalled32

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

Timeline

21 Apr 2026Recall initiated by company
23 Jun 2026Classified by FDA+63 days
1 Jul 2026Published 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.

Nationwide MarylandNew York

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.

More recalls from PFM Medical

All 10
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIAsept Drainage recalled by Pfm MedicalPfm MedicalOtherNationwide
DeviceCLASS IIAsept Drainage Kit recalled by Pfm MedicalPfm MedicalOtherNationwide
DeviceCLASS IIRapid Centesis Catheter recalled by Pfm MedicalPfm MedicalOtherNationwide
DeviceCLASS IIThoracentesis & Paracentesis Procedure Tray recalled by Pfm MedicalPfm MedicalOtherNationwide
DeviceCLASS IIVeta Peritoneal Catheter Kit, Curled recalled by Pfm MedicalPfm MedicalOtherNationwide

Other Other Medical Devices recalls

All 13,908