Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnosti
FDA device recall Z-2615-2026 · posted 2026-07-02 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NLH
- Quantity affected
- 3
- Distribution
- US Nationwide distribution in the state of TX.
- Date initiated
- 2026-05-15
- Date posted
- 2026-07-02
- Location
- Northfield, IL
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