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U.S. Department of Health and Human Services

Class 1 Device Recall Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter

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 Class 1 Device Recall Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Cathetersee related information
Date Initiated by FirmMay 15, 2026
Date PostedJuly 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2615-2026
Recall Event ID 99122
510(K)NumberK241156 
Product Classification Catheter, recording, electrode, reprocessed - Product Code NLH
ProductReprocessed 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.
Code Information Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer 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 2		Under Investigation by firm
ActionThis 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.
Quantity in Commerce3
DistributionUS Nationwide distribution in the state of TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NLH
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