Recall
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
American Contract Systems Inc · 6 Feb 2025
- Status
- Recall open, classified
- Why, in the FDA's words
- “ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.”
- Recall began
- 6 Feb 2025
- Company
- American Contract Systems Inc
- Device type
- Product code (LRO)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.