HIGH

Medline Recalls Catheters Due to Infection Risk from Residual Particulates

Medline Industries recalled 7,913 reprocessed electrophysiology catheters on July 31, 2025. The recall affects specific lots that may contain harmful particulates. Using these catheters could lead to serious health risks including embolism or deep vein thrombosis.

Quick Facts at a Glance

Recall Date
July 31, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall includes reprocessed Webster CS Catheter 10 Electrodes with Medline Item Numbers BD710DF282CRH, BD710DF282RRH, BD710FJ282CRH, and BD710FJ282RRH. These devices were distributed nationwide in the U.S. No price information is available.

The Hazard

Certain lots of these catheters may have small residual particulates on patient-contacting surfaces. These particulates can cause an inflammatory response or systemic infection.

Reported Incidents

There are no reported incidents or injuries at this time. However, the potential risks include granulomatous reactions, thrombus formation, and serious conditions like cerebral or pulmonary embolism.

What to Do

Stop using the recalled catheters immediately. Patients and healthcare providers should follow the manufacturer's recall instructions and contact Medline Industries for guidance.

Contact Information

For further assistance, contact Medline Industries, LP at the phone number listed on their website. More details are available at the FDA recall page.

Key Facts

  • Recall date: July 31, 2025
  • Report date: October 8, 2025
  • Quantity recalled: 7,913 units
  • Potential health risks: Inflammation, infection, embolism

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Item Number/UDI-DI BD710DF282CRH 10197344044023
BD710DF282RRH 10197344044030
BD710FJ282CRH 10197344044047
BD710FJ282RRH 10197344044054
LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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