Use cautionMedical device recall · FDA · Published May 15, 2026
Medline Reprocessed Catheters Recall: Risk of Infection from Residual Particles
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.
Take action
Contact the company
📍Recalling firmMedline Industries, LP3 Lakes Dr · Northfield, IL 60093-2753
“Medline Reprocessed Catheters Recall: Risk of Infection from Residual Particles.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49160-medline-reprocessed-catheters-recall-risk-of-infection-from-residual-particles. Based on FDA recall #Z-2615-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2615-2026%22&limit=1).
The FDA announced on May 15, 2026, that Medline Industries, LP is recalling reprocessed electrophysiology and ultrasound catheters due to potential residual material particles. The agency issued recall number Z-2615-2026 for the voluntary Class I recall.
How to tell if you have it
Brand: Medline
Product: 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.
Distribution: US Nationwide distribution in the state of TX
Units affected: 3
The hazard
Specific lots of reprocessed catheters may contain small particles of residual material on patient-contacting surfaces. If used, these particulates pose a potential risk of inflammatory response or systemic infection. Dislodged particles contacting circulating blood or the heart may produce granulomatous reaction or thrombus formation, potentially leading to cerebral or pulmonary embolism, or deep vein thrombosis.
Context
GovInfoNow's records show Medline Industries, LP has 68 other recalls on record since July 31, 2025. Other recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (April 21, 2026), Getinge Thoracic Catheter Recall (August 7, 2026), and Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026).
How to tell if you have this one
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.
Brand
Medline
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Review the item number and lot number on the device to confirm if it matches the recalled models and lots.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 54 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-2615-2026 (May 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2615-2026 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.