GS Endoscopy Pack recalled for improper resterilization and discoloration
AVID Medical is recalling the GS Endoscopy Pack due to inadvertent resterilization that caused discoloration of the visualization system. The recall affects 816 units distributed across seven states.
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: FDA Class II medical device recall involving a sterilization defect that poses a risk of harm. Although no illnesses or injuries have been reported, improper sterilization of endoscopy equipment creates a genuine safety risk in medical procedures.
Plain-English summary
AVID Medical, Inc. is recalling the GS Endoscopy Pack, a medical convenience kit, due to a sterilization processing error. The recalled kits were inadvertently resterilized, which caused discoloration of the Clearify Visualization System component.
The recall affects 816 units distributed domestically across California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. Affected products include Model Numbers NAMC421-10, NAMC421-11, and NAMC421-12, with specific lot numbers identified in the FDA recall notice.
The recalled product
- Product
- GS ENDOSCOPY PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- 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 (17)
- Model No. NAMC421-10
- NAMC421-11
- NAMC421-12
- UDI: 10809160374597
- 10809160417539
- 10809160435779
- Kit Lot No. 1584375
- 1588403
- 1605341
- 1615427
- 1615428
- 1627706
- 1628153
- 1628008
- 1628009
- 1628647
- 1632992.
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