Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name:… — Class II medical device recall Z-0574-2026
Ongoing recall by Sterilmed, Inc., reported 2025-11-26, distributed in KY, MA, MD, MS, NJ, PA, TX, UT. Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanica
| Recall number | Z-0574-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sterilmed, Inc., Plymouth, MN, United States |
| Recall initiated | 2025-10-08 |
| Classified | 2025-11-20 |
| Reported by FDA | 2025-11-26 |
| Distributed | KY, MA, MD, MS, NJ, PA, TX, UT |
| Quantity | 4 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10888551004732 |
| Lot numbers | 1050886, 1170283, 131065, 2188147, 2207154, 2220232, 2234795, 916179 |
| Serial numbers | 1050886, 1170283, 131065, 2188147, 2207154, 2220232, 2234795, 916179 |
| Model numbers | ACU10135936 |
Product
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
Reason for recall
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
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-0574-2026. 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.