Robotic Partial Nephrectomy Kit Recalled for Sterilization Integrity Issue
AVID Medical is recalling 46 robotic partial nephrectomy surgery kits due to inadvertent re-sterilization of the visualization system component, which caused discoloration.
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 medical device recall for a surgical kit component that was inadvertently re-sterilized, causing discoloration. The recall represents a risk-of-harm medical device where no injuries have been reported, meeting the High severity criterion.
Plain-English summary
AVID Medical, Inc. is recalling 46 units of its PARTIAL NEPHRECTOMY - ROBOTIC medical convenience kit due to inadvertent re-sterilization of the CLEARIFY VISUALIZATION SYSTEM component, which resulted in discoloration.
The affected kits were distributed domestically across California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. The recalled units include Model No. NIHB0035-07 with the following lot numbers: 1591938, 1622268, 1628944, and 1632685.
No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- sterilization-failure
- discoloration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model No. NIHB0035-07
- UDI: 10809160404959
- Kit Lot No. 1591938
- 1622268
- 1628944
- 1632685.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03