Reprocessed Webster CS Catheter 10 Electrodes for… recallZ-2611-2025 · Medline Industries, LP · initiated Jul 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
On 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.
Recall details
- Recall number
- Z-2611-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2025
- Posted by the FDA
- Sep 26, 2025
- Recalling firm
- Medline Industries, LP
- Quantity
- 7913 eaches
- Product code
- NLH
- FDA submissions
- K241224
- Distribution
- Domestic US distribution nationwide. International distribution pending. No international distribution.
Product description
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Code information (models, lots, serial numbers)
Item Number/UDI-DI BD710DF282CRH 10197344044023; BD710DF282RRH 10197344044030; BD710FJ282CRH 10197344044047; BD710FJ282RRH 10197344044054; LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE BD710DF282CRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710DF282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710FJ282CRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710FJ282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97496).
- Z-2610-2025 · Open, ClassifiedReprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH …
- Z-2612-2025 · Open, ClassifiedReprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 8110…
- Z-2613-2025 · Open, ClassifiedReprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
- Z-2614-2025 · Open, ClassifiedReprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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