Medline recalls reprocessed electrophysiology and ultrasound catheters with potential residual particles that could cause infection or blood clots if used. Affected lots include specific item numbers and dates.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Medline is recalling reprocessed electrophysiology and ultrasound catheters that may contain small particles of residual material. Using these devices could lead to infections or blood clots if particles enter the bloodstream.
Residual particles from reprocessing may remain on the device surfaces. If these particles dislodge during use and enter the bloodstream, they could cause inflammation, infections, or blood clots that might lead to serious complications.
Healthcare professionals using these catheters in medical procedures are most at risk. Patients receiving procedures with the recalled devices could face complications.
Check for item numbers 401206RH or 401305RH with specific lot numbers like EP250203. The devices were sold with unique identifiers (UDI-DI) such as 10197344043767 or 10197344043637.
Review the item number and lot number on the device to confirm if it matches the recalled models and lots.
The recall is due to potential residual particles in reprocessed catheters that could cause infections or blood clots if particles enter the bloodstream.
Check the item number and lot number on the device to see if it matches the recalled models and lots. Contact Medline for further instructions.
Yes, using devices with residual particles could lead to infections or blood clots, which might cause serious complications like pulmonary embolism.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2615-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2615-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
