Medline Industries Recalls Reprocessed ViewFlex Xtra ICE Catheters Due to Potential Particle Contamination

What Happened

Medline Industries, LP has initiated a voluntary Class I recall of specific lots of reprocessed ViewFlex Xtra ICE Catheters. The recall was triggered because these reprocessed devices may contain small particles of residual material. If these affected devices are used during medical procedures, there is a significant risk of an inflammatory response, systemic infection, or granulomatous reaction. Furthermore, the presence of these particles could cause a thrombus reaction, potentially leading to life-threatening conditions such as cerebral or pulmonary embolism, or deep vein thrombosis.

Which Products Are Affected

The recall affects 650 units distributed nationwide across the United States. The specific products involved are:

• Product Name: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters
• Model: ViewFlex Xtra ICE Catheter 9F x 90cm (D087031RH)
• UDI-DI (Case): 20197344019554
• UDI-DI (Each): 10197344019557
• Affected Lot Numbers: EP250324, EP250416, EP250512, EP250521, EP250609, EP250630, EP250710, and EP250724.
• Recall Number: Z-1323-2026

What You Should Do

Medline Industries, LP notified affected customers via a formal letter initiated on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the specific lot numbers listed above. Any affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or specific guidance, facilities should contact Medline Industries, LP directly.

Why This Matters

This is a Class I recall, the most serious category, indicating that the use of the affected product could cause serious health consequences or death. The potential for residual material to enter the bloodstream poses a direct risk of embolism or severe systemic infection.

Source

Information provided by the FDA.