Medline Industries Recalls Reprocessed Webster CS Catheters Due to Potential Residual Material

FDA Recalls high FDA · · United States

Medline Industries, LP has issued a Class I recall for 228 reprocessed Webster CS Catheters that may contain residual material particles, posing a risk of embolism or infection.

What Happened

Medline Industries, LP has initiated a voluntary Class I recall of specific lots of Medline ReNewal Reprocessed Webster CS Catheters. The recall was triggered by the discovery that these reprocessed devices may contain small particles of residual material. The FDA has classified this as a Class I recall, indicating that the use of these devices could cause serious adverse health consequences or death.

Which Products Are Affected

A total of 228 units distributed nationwide in the United States are affected. The recall includes the following models and lot numbers (EP250429 and EP250808 for all listed):

  • Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer: Model BD710DF282CRH (UDI-DI 10197344044023)
  • Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer: Model BD710DF282RRH (UDI-DI 10197344044030)
  • Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer: Model BD710FJ282RRH (UDI-DI 10197344044054)
  • Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer: Model BD710FJ282CRH (UDI-DI case 40197344044048; ea 10197344044047)

What You Should Do

Medline Industries notified affected customers via letter starting December 22, 2025. Healthcare facilities and providers should immediately identify and quarantine any affected catheters from the specified lots. Facilities should follow the instructions provided in the firm’s notification letter for the return or disposal of the products. For further information, facilities can contact Medline Industries, LP directly at their Northfield, IL headquarters.

Why This Matters

The use of catheters containing residual material poses significant health risks, including inflammatory responses, systemic infections, or thrombus reactions. These conditions may lead to life-threatening complications such as cerebral embolism, pulmonary embolism, or deep vein thrombosis.

Source

Information provided by the FDA under recall number Z-1319-2026.

Source: FDA Official Notice

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