Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554
FDA Recall Z-1323-2026 · Posted 2026-02-06
Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOWQ
Date Initiated2025-12-22
Product Quantity650
Reason for Recall
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
Firm Action
On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer.
***Updated 5/18/26***
The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution US nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.