PV Bulletin

Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters

Expansion of the recall for specific reprocessed catheters that may pose serious health risks.

Primary source: What is an Early Alert?

PV Impact Brief

Urgency: HighConfidence: high

What changed

The recall now includes additional lot numbers, increasing the scope of affected products that must be quarantined and destroyed.

Why it matters

Continued use of these catheters may lead to serious injuries or fatalities due to potential infection or embolism risks associated with the residual particulates.

Action needed

Immediate quarantine and destruction of all affected lots are mandated. Affected inventory must be checked, and customers must be notified if products have been resold or transferred.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 2, 2026

Full briefing

Practical implication

Immediate quarantine and destruction of all affected lots are mandated. Affected inventory must be checked, and customers must be notified if products have been resold or transferred.

Medline Industries is recalling certain reprocessed electrophysiology and ultrasound catheters identified as potentially containing residual particulates, risking serious health complications if used. This recall has been classified as Class I, indicating it is the most serious type.

What changed: The recall now includes additional lot numbers, increasing the scope of affected products that must be quarantined and destroyed.

Why it matters: Continued use of these catheters may lead to serious injuries or fatalities due to potential infection or embolism risks associated with the residual particulates.

Practical implication: Immediate quarantine and destruction of all affected lots are mandated. Affected inventory must be checked, and customers must be notified if products have been resold or transferred.

View original source

  • Source: FDA - MedWatch Safety Alerts RSS
  • Published at source: 2026-09-02T00:00:00.000Z
  • Discovered by monitor: 2026-09-03T21:47:54.033Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Usa#Fda.gov

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