[Recalled] URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 — ACS is unable to confirm product sterilization assurance requirements were met | FDA 2025-02-06

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from American Contract Systems Inc

• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR — Class II
• TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF — Class II
• MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02 — Class II
• UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG — Class II
• HAND PACK-Procedure Kit Catalog Number: WEHD16B — Class II
• ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.