Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex… — Class I medical device recall Z-1323-2026
Ongoing recall by Medline Industries, LP, reported 2026-02-18, distributed nationwide. These lots of reprocessed catheters may contain small particles of residual material. If affected devices are
| Recall number | Z-1323-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-12-22 |
| Classified | 2026-02-06 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 650 |
| UPC / GTIN / UDI-DI | 10197344019557, 20197344019554 |
| Lot numbers | 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¿
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1323-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.