Recall Z-1323-2026 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Medline Industries, LP
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554
| Date | Feb 6, 2026 (initiated Dec 22, 2025) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by 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 |
| Quantity | 650 |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter Surgical Instrument Services and Savings, Inc., Dec 15, 2023 |