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U.S. Department of Health and Human Services

Class 1 Device Recall Medline ReNewal Reprocessed BW Webster CS Catheter with EZ Steer Technology; and Auto ID Technology

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 Class 1 Device Recall Medline ReNewal Reprocessed BW Webster CS Catheter with EZ Steer Technology; and Auto ID Technologysee related information
Date Initiated by FirmJuly 31, 2025
Date PostedSeptember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2611-2025
Recall Event ID 97496
510(K)NumberK241224 
Product Classification Catheter, recording, electrode, reprocessed - Product Code NLH
ProductReprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Code Information Item Number/UDI-DI BD710DF282CRH 10197344044023; BD710DF282RRH 10197344044030; BD710FJ282CRH 10197344044047; BD710FJ282RRH 10197344044054; LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/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
ActionOn July 31, 2025, the firm notified customers via first class mail and email of the potential product issue. An updated letter was sent to customers on 8/13/25 with additional item and lot numbers. Affected products are to be returned for credit. Customers were instructed to immediately identify and quarantine all affected product within their possession. Once they have completed and returned the response form listing their affected inventory, they will receive return labels and RGA information. Customers will receive credit when the returned product is received.
Quantity in Commerce7913 eaches
DistributionDomestic US distribution nationwide. International distribution pending. No international distribution.
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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