FDA-Device2026-02-18Class IPROCESSING DEFECT

Medline ReNewal Webster CS Catheters recalled for residual particles and infection risk

OTHERNationwide distributionMedical devices

What this means

Medline Industries is recalling certain reprocessed Webster CS Catheters because they may contain small particles of leftover material from cleaning. If used, these particles could trigger inflammation, infection, blood clots, or serious complications like stroke or lung clots.

  • Stop using affected catheters immediately if you have them
  • Check your device lot number against BD710DF282CRH, BD710DF282RRH, BD710FJ282RRH, or BD710FJ282CRH with lots EP250429 or EP250808
  • Contact Medline or your healthcare provider for instructions on returning or replacing the device
  • Seek medical attention if you experience signs of infection, inflammation, or blood clots
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The agency's original wording
Hazard

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide.
Affected count
228
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1319-2026

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