Medical device kits recalled for discoloration from improper resterilization
AVID Medical is recalling 656 PACK GENERAL ROBOTIC medical convenience kits that were inadvertently resterilized, causing discoloration. The defective kits were distributed in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall with no reported illnesses or injuries. The stated hazard is discoloration from resterilization, a cosmetic/appearance issue without clinical risk indicators. Per the rubric, recalls with minor defects and no reported harm are classified Moderate.
Plain-English summary
AVID Medical, Inc. is recalling 656 units of PACK GENERAL ROBOTIC Medical convenience kits. The recalled products contain a CLEARIFY VISUALIZATION SYSTEM component and include lot numbers 1589630, 1590570, 1610157, 1617028, 1618142, 1621537, 1629589, 1635288, and 1636852.
The CLEARIFY VISUALIZATION SYSTEM component in these kits was inadvertently resterilized during production, resulting in discoloration. This product recall has been classified as a Class II recall by the U.S. Food and Drug Administration.
The affected kits were distributed domestically to California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. Consumers and healthcare providers should verify lot numbers when handling or using these kits.
The recalled product
- Product
- PACK GENERAL ROBOTIC. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Medical Kit
- Hazard
- sterilization-defect
- 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 (11)
- Model No. RDLD047-10
- UDI: 10809160358603
- Kit Lot No. 1589630
- 1590570
- 1610157
- 1617028
- 1618142
- 1621537
- 1629589
- 1635288
- 1636852.
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