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Home › FDA recalls › Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:
CLASS I · SeriousFDA

Medline Industries, LP recalls Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F

📅 Dec 22, 2025 · 📍 Nationwide
Recalling company
Medline Industries, LP
Product
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
Reason
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
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Dec 22, 2025
Reported
Feb 18, 2026
Distribution
Distribution US nationwide.
Status
Ongoing
Quantity
650
Lot / codes
UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-1323-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1323-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.