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

Medline Reprocessed Webster CS Catheter Recalled for Residual Particulates

Medline Industries recalled certain lots of reprocessed Webster CS Catheters due to residual particulates on patient-contacting surfaces that may cause infection, blood clots, or embolism.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. Per the rubric, FDA Class I recalls must score at minimum 4. No illnesses or injuries are reported in the source text.

Plain-English summary

Medline Industries, LP is recalling specific lots of reprocessed Webster CS Catheters with 10 electrodes used for electrophysiological mapping of cardiac structures. Approximately 7,913 units have been distributed domestically in the United States. The affected lot numbers are EP241216, EP241218, EP241226, EP241231, EP250110, EP250121, and EP250210.

The specific lots of catheters may contain small residual particulates on patient-contacting surfaces that were not completely removed during the reprocessing of the devices.

If a device containing residual particulates is used, there is potential risk of an inflammatory response or systemic infection. If the particulate dislodges during use and contacts circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation. These complications may lead to cerebral embolism, 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
Hazard
  • particulate-contamination
  • infection
  • thrombosis
  • embolism

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.