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Reprocessed Electrophysiology and Ultrasound Catheters
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MEDICAL DEVICE RECALLCRITICAL

Reprocessed Electrophysiology and Ultrasound Catheters

Medline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.

What to do

Healthcare facilities should immediately check their inventory for the affected catalog numbers, quarantine any remaining stock, and contact the manufacturer for return instructions.

Posted
Updated
Recall No.
Z-2615-2026
Agency
Firm
Medline Industries, LP
Recall ID
99122
Status
ONGOING

Why it was recalled

Medline Industries is recalling specific reprocessed catheters due to the presence of residual particulate matter on patient-contacting surfaces. Use of these devices may cause inflammatory responses, systemic infection, or serious complications such as thrombus formation and embolism. The affected items are identified by specific catalog numbers.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.

UPC
10197344043767, 10197344043637
Recall #
Z-2615-2026

Where it was sold

Distributed nationwide.

Other recent recalls from Medline Industries, LP

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Editorial summary by Recall Canary · last updated 2026-07-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification