FDAFDA recall Z-2615-2026 · Jul 8, 2026
Medline Industries, LP: Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall
Recall found
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.
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the state of TX.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-15
Source: openFDA enforcement record Z-2615-2026 · search recall number Z-2615-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.