RegWardenFDA facility compliance records
Company

PFM Medical

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2014: 1 recalls; 2026: 1 recalls1’14’15’16’17’18’19’20’21’22’23’24’251’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-04-21
    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 inflammatio…
  • Class IITerminated2014-10-20
    PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “PFM Medical — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9020573-pfm-medical/

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