Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters:… — Class I medical device recall Z-1325-2026
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-1325-2026 |
|---|---|
| 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 | 511 |
| UPC / GTIN / UDI-DI | 10197344026500, 10197344026517 |
| Lot numbers | 10135936RH, EP250324, EP250429, EP250521, EP250609, EP250630, EP250710, EP250905 |
Product
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
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-1325-2026. 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.