Reprocessed Electrophysiology and Ultrasound Catheters
Medline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.
Healthcare facilities should immediately check their inventory for the affected catalog numbers, quarantine any remaining stock, and contact the manufacturer for return instructions.
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.
- Lot code
- EP250203, 401206RH
- UDI-DI
- 10197344043767, 10197344043637
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Foreign Material recalls
Other recent recalls from Medline Industries, LP
Editorial summary by Recall Canary · summary updated 2026-07-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification