Z-2615-2026 Class I Ongoing
FDA device recall Z-2615-2026 was initiated by Medline Industries, LP on May 15, 2026 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
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.
Distribution Pattern
US Nationwide distribution in the state of TX.
Code Information
Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.