Partial Nephrectomy Pack Recalled Due to Visualization System Discoloration
AVID Medical is recalling Partial Nephrectomy Packs (52 units) because the CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized, causing 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 Class II medical device recall involves a critical component in a surgical kit. A visualization system essential for safe surgical performance was damaged through improper resterilization. Although no injuries have been reported, this represents a risk-of-harm product in a surgical context.
Plain-English summary
AVID Medical, Inc. is recalling Partial Nephrectomy Packs (Model No. NAMC077, NAMC077-02) distributed domestically in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. A total of 52 units are affected by this Class II recall.
The CLEARIFY VISUALIZATION SYSTEM component included in these kits was inadvertently resterilized, causing discoloration. Due to this discoloration, the affected kits should not be used.
Affected lot numbers are 1591073, 1612261, 1616916, 1632036, 1632038, and 1632359. Healthcare providers who have received these kits should stop using them immediately and contact AVID Medical, Inc. for replacement or return instructions.
No injuries or adverse events have been reported in connection with this recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- device-discoloration
- visualization-impairment
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 (10)
- Model No. NAMC077
- NAMC077-02
- UDI: 10809160318911
- 10809160437971
- Kit Lot No. 1591073
- 1612261
- 1616916
- 1632036
- 1632038
- 1632359.
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