Lower riskMedical device recall · FDA · Published July 14, 2025
Medline ReNewal Reprocessed St. Jude Catheters May Contain Particulates
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.
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Contact the company
📍Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/51791-medline-renewal-reprocessed-st-jude-catheters-may-contain-particulates.
“Medline ReNewal Reprocessed St. Jude Catheters May Contain Particulates.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51791-medline-renewal-reprocessed-st-jude-catheters-may-contain-particulates. Based on FDA recall #Z-2460-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2460-2025%22&limit=1).
The FDA announced on July 14, 2025, that Medline Industries LP is recalling specific lots of Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters due to potential residual particulates. The recall affects 398 units distributed nationwide.
How to tell if you have it
Brand: Medline
Product: Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. The FDA classified this recall as Class I.
Context
GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since 2021-10-22. Other recent recalls of similar products include Medline medical kits with light failure (2025-07-25), Foley Tray Kits with incorrect labeling risk (2025-07-23), and Medline Surgery Tray Recall involving tourniquet cuff detachment (2025-07-08). Other recent recalls of similar products include St. Jude Medical Reprocessed Catheters Recall for infection risk (2025-12-22), Medline Reprocessed Catheters Recall for infection risk (2026-05-15), and Medline ReNewal Reprocessed Webster CS Catheters Recall for infection risk (2025-12-22).
How to tell if you have this one
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.
Brand
Medline
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
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.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2460-2025 (July 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2460-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.