Medline recalls specific lots of reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters due to potential small residual particulates that could cause injury during medical procedures.
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Medline is recalling specific lots of reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters because some may contain small residual particulates. This could pose a risk of injury during medical procedures if the catheters are used without proper cleaning.
The catheters may contain small residual particulates from the reprocessing process. If these particles are introduced into the body during medical procedures, they could cause tissue damage or other complications.
Healthcare professionals who use these catheters in medical procedures may be affected. Patients receiving procedures with these catheters could be at risk if particulates cause complications.
Check for model numbers 401150RH through 402012RH with specific lot numbers listed in the recall notice. The catheters have UDI-DI codes and lot numbers starting with EP241118 or EP250106.
Identify the model number and lot number on the catheter packaging or label to see if it matches the recalled items listed in the notice.
The recall indicates that specific lots may contain small residual particulates that could cause injury during medical procedures. Using these specific lots without proper cleaning could pose a risk.
Check the model number and lot number on the catheter. The recalled items include specific model numbers (401150RH through 402012RH) with lot numbers starting with EP241118 or EP250106.
The recall does not specify a remedy, so contact Medline directly to determine if your catheter is affected and what steps to take.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2460-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-2460-2025 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.
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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.
