| Date Initiated by Firm | December 22, 2025 |
|---|
| Date Posted | February 06, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1323-2026 |
|---|
| Recall Event ID |
98277 |
| 510(K)Number | K232130 |
|---|
| Product Classification |
Reprocessed intravascular ultrasound catheter - Product Code OWQ
|
| Product | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:
ViewFlex Xtra ICE Catheter 9F x 90cm
D087031RH
20197344019554 |
|---|
| Code Information |
UDI-DI (case) 20197344019554¿
(ea) 10197344019557
Lots
EP250324
EP250416
EP250512
EP250521
EP250609
EP250630
EP250710
EP250724
|
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield
IL
60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
|---|
Manufacturer 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 |
|---|
FDA Determined
Cause 2 | 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 since expired. |
|---|
| Quantity in Commerce | 650 |
|---|
| Distribution | Distribution US nationwide. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = OWQ
|
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