FDAClass IIMarch 26, 2025

URO Robotic Pack recall

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

Why was URO Robotic Pack recalled?

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 00191072136688 Lots 905241 70-050739 70-051020 70-051480 70-051606 70-051888

Product
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Recalling firm
American Contract Systems Inc
Quantity
41 kits
Distribution
US Nationwide distribution in the state of OH.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls