HIGH

Medline Recalled 7,913 Reprocessed Webster CS Catheters for Electrophysiology Mapping

Medline Industries recalled 7,913 reprocessed Webster CS Catheters for electrophysiology mapping nationwide in the United States. The recall concerns small residual particulates on patient-contacting surfaces that could trigger inflammatory responses or systemic infection. If particulates dislodge and contact circulating blood or the heart, they could cause granulomatous reactions or thrombus, and

Quick Facts at a Glance

Recall Date
July 31, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
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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About This Product

These catheters are used in electrophysiology mapping and ultrasound imaging for cardiac procedures. They are reprocessed devices intended for patient-contact during mapping.

Why This Is Dangerous

Residual particulates on patient-contacting surfaces pose infection or inflammatory risks. Dislodged particulates can cause granulomatous reactions or thrombi, leading to embolism.

Industry Context

This recall is not described as part of a broader pattern in the provided data.

Real-World Impact

Clinical risk exists during procedures using these catheters. No injuries are reported in the recall to date, but the potential for serious adverse events could result in extended hospital stays or additional surgeries if particulates cause embolic complications.

Practical Guidance

How to identify if yours is affected

  1. Check item numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
  2. Verify lots EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
  3. Compare packaging and labeling to recall notice

Where to find product info

Lots and item numbers appear on device labeling and accompanying documentation provided with the lot

What timeline to expect

Remedy timing is determined by Medline. Recalls of this type typically resolve within weeks to months following notice.

If the manufacturer is unresponsive

  • Escalate to FDA recall contact
  • Consult healthcare provider for alternatives and documentation guidance

How to prevent similar issues

  • When purchasing reprocessed medical devices, verify sterilization and lot control
  • Follow manufacturer and FDA recall communications
  • Ask suppliers for COA or sterilization verification

Documentation advice

Keep recall letter, item numbers, lot numbers, and all communications with healthcare providers for records

Product Details

Medline Industries BD710DF282CRH, BD710DF282RRH, BD710FJ282CRH, BD710FJ282RRH reprocessed catheter lots. Domestic US distribution nationwide. International distribution pending. Quantity 7913 es. No international distribution.

Reported Incidents

No injuries or incidents have been reported. This section reflects the information provided in the recall notice.

Key Facts

  • Total units recalled: 7,913 es
  • Recall date: 2025-07-31
  • Hazard level: HIGH
  • Item numbers: BD710DF282CRH, BD710DF282RRH, BD710FJ282CRH, BD710FJ282RRH
  • Lots: EP241216, EP241218, EP241226, EP241231, EP250110, EP250121, EP250210
  • Distribution: Domestic US nationwide

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Model Numbers
BD710DF282CRH
BD710DF282RRH
BD710FJ282CRH
BD710FJ282RRH
LOTS EP241216
+6 more
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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