Medline Industries Recalls Reprocessed St. Jude Diagnostic Electrophysiology Catheters Due to Contamination Risk

What Happened

Medline Industries, LP has initiated a voluntary Class I recall of specific lots of reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters. The FDA has classified this as a Class I recall, indicating a high risk of serious health consequences. The affected devices may contain small particles of residual material. If used, these contaminated catheters can cause inflammatory responses, systemic infections, granulomatous reactions, or thrombus reactions, which may lead to life-threatening conditions such as cerebral or pulmonary embolism or deep vein thrombosis.

Which Products Are Affected

The recall involves 48 units distributed nationwide across the United States. Affected products include various models of reprocessed St. Jude Medical Supreme Diagnostic Electrophysiology Catheters (4 Elec. and 6 Elec.) with the following model numbers:

• 4 Elec. 2-5-2mm: 401211RH, 401222RH, 401223RH, 401226RH, 401227RH, 401260RH, 401261RH, 401306RH, 401309RH, 401312RH, 401430RH, 401433RH, 401435RH, 401441RH, 401442RH, 401443RH, 401448RH, 401449RH, 401450RH, 401451RH, 401474RH, 401860RH, 401877RH, 401878RH, 401890RH, 401891RH, 401994RH
• 4 Elec. 5-5-5mm: 402012RH
• 4 Elec. 5mm: 402004RH
• 6 Elec. 2-5-2mm: 402010RH
• 6 Elec. 5-5-5mm: 402008RH, 402009RH

Affected lot numbers include EP250307 and EP250317. The recall is identified by FDA Recall Number Z-1322-2026.

What You Should Do

Medline Industries began notifying customers via letter on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and not used for patient procedures. For information regarding returns or further instructions, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.

Why This Matters

This recall is significant because the presence of foreign particles in medical devices used in the cardiovascular system can lead to severe, potentially fatal complications, including strokes or blood clots in the lungs.

Source

Information provided by the FDA.