FDAClass IFebruary 18, 2026

Medline ReNewal Reprocessed ViewFlex Xtra ICE recall

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿

Why was Medline ReNewal Reprocessed ViewFlex Xtra ICE recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724

Product
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
Recalling firm
Medline Industries, LP
Quantity
650
Distribution
Distribution US nationwide.
Recall date
February 18, 2026
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls