PFM Medical Multi-Snare Set Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
PFM Medical Inc. is recalling 32 Multi-Snare Sets distributed in NY and MD after failing biocompatibility testing.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 5, 2026 and geographically references New York, Maryland. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
PFM MEDICAL INC. initiated a voluntary recall of Multi-Snare Sets because the snare catheter including luer lock failed to meet the biocompatibility requirements for in-vitro-cytotoxicity. If in contact with a patient's vasculature, this could result in localized inflammation and tissue irritation.
Which Products Are Affected
The recall covers 32 units of the following products distributed in the states of NY and MD:
- Multi-Snare Set: 5 mm x 125 cm, REF: 147305
- Multi-Snare Set: 10 mm x 125 cm, REF: 147310
Lot information: 147305/04042301061829/1049868 (exp. 10/14/2028); 147310/04042301033567/1049960 (exp. 10/20/28). Recall number Z-2526-2026. Classification: Class II.
What You Should Do
Consumers and healthcare facilities should stop using the affected devices and contact PFM MEDICAL INC. for return or refund instructions.
Why This Matters
The recall affects devices used for removal or manipulation of foreign bodies in the vascular system, with potential for localized inflammation if biocompatibility issues occur.
Source
FDA recall Z-2526-2026 (event ID 98942).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,114 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
Common questions about this FDA recall.