Recall Z-2615-2026
Medline Industries, LP · initiated May 15, 2026
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
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.
FDA-determined cause: Under Investigation by firm
Action taken
This is an expansion of recall RES 98277. On May 15, 2026, firm notified affected consignee via letter titled "URGENT MEDICAL DEVICE RECALL". All affected product has expired. The consignee was instructed to quarantine all affected product and destroy it.
Details
- Recall number
- Z-2615-2026
- Initiated
- May 15, 2026
- Posted by FDA
- July 2, 2026
- Product code
- NLH – Catheter, Recording, Electrode, Reprocessed
- Quantity
- 3
- Distribution
- US Nationwide distribution in the state of TX.
- Recalling firm
- Medline Industries, LP, Northfield, IL