FDA recall, , High risk
Medline Reprocessed Electrophysiology and Ultrasound Catheters
Reprocessed electrophysiology catheters may contain small particles of residual material, posing a risk of inflammatory response or infection.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalls Reprocessed Electrophysiology Catheters and Ultrasound Catheters, including St. Jude Medical Response Diagnostic Electrophysiology Catheters, because specific lots 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, and if particulate were to dislodge during use and contact circulating blood or the heart, additional risk may occur.
The recall began on May 15, 2026, and was added to the FDA's Enforcement Report on July 2, 2026. Distribution was in the state of Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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.- UDI-DI
- 10197344043767
- 10197344043637
- Lot code
- EP250203
- 401206RH
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Texas.
- Company
- Medline Industries, LPNorthfield, Illinois
- Follows FDA recall
- Medline ReNewal Reprocessed Diagnostic Catheters (FDA 98277)
- Hazard
- Foreign object
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99122
- Recall number
- Z-2615-2026
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
