FDA Recalls URO Robotic Pack Surgical Kit Due to Sterilization Concerns
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall involving sterile medical devices where sterilization assurance cannot be confirmed. The potential for non-sterile surgical equipment to cause treatment delays and loss of functionality represents a risk-of-harm scenario. No illnesses or injuries have been reported, which per the rubric limits this to High (3) severity.
Plain-English summary
American Contract Systems Inc has recalled 41 units of the URO ROBOTIC PACK, Model No LVUR44C (LVUR44C-03), distributed in Ohio. The recall affects the following lot numbers: 905241, 70-050739, 70-051020, 70-051480, 70-051606, and 70-051888.
The manufacturer was unable to confirm that product sterilization assurance requirements were met. This means the manufacturer cannot guarantee that the surgical kits are sterile, a critical requirement for medical devices used in surgical procedures.
The potential risks from non-sterile surgical equipment include loss or lack of functionality, which could lead to delayed treatment or prolonged medical procedures. No illnesses or injuries have been reported to date.
Patients or healthcare providers who have these units should contact American Contract Systems Inc to determine whether their specific lot number is affected and for guidance on next steps.
The recalled product
- Product
- URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- treatment-delay
- loss-of-functionality
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03