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Serious riskFDA DeviceClass I

Medline ViewFlex Xtra ICE catheters recalled for possible particles

Medline Industries is recalling certain lots of reprocessed ViewFlex Xtra ICE Catheters (9F x 90cm) because they may contain small particles of leftover material inside the device. If used, these particles could trigger inflammation, infection, blood clots, or other serious complications.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if you have a catheter from lots EP250324, EP250416, EP250512, EP250521, EP250609, EP250630, EP250710, or EP250724
  2. Stop using affected catheters immediately
  3. Contact Medline Industries or your healthcare provider for instructions on replacement or proper disposal
  4. Report any adverse effects to the FDA MedWatch program if complications occur
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
650
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-1323-2026

In the FDA's words

Description
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿ 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 UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724 Distribution: Distribution US nationwide. Affected quantity: 650
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

7 products in this recall

Medline, Abbott and more catheters recalled for embolism risk

Medline is recalling seven groups of reprocessed heart and ultrasound catheters because they may contain small particles of leftover material. If these devices are used, the particles could cause inflammation, infection, or blood clots, which may lead to embolism or deep vein thrombosis. This is an expansion of an earlier recall, and the affected catheters were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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