The Recall Desk
Severity pendingFDA (Devices)·Z-2611-2025·Announced 2025-10-08

Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures

Pending LLM rewrite. Source: FDA_DEVICE Z-2611-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Manufacturer
Medline Industries, LP

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Item Number/UDI-DI BD710DF282CRH 10197344044023
  • BD710DF282RRH 10197344044030
  • BD710FJ282CRH 10197344044047
  • BD710FJ282RRH 10197344044054
  • LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210

Distribution

Distributed nationwide across the United States.