GS Endoscopy Pack (Avid Medical) – Visualization System Discoloration (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GS ENDOSCOPY PACK. Medical convenience kit.
Brand
AVID Medical, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
AVID Medical, Inc. is recalling GS ENDOSCOPY PACK. Medical convenience kit. due to CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Recommended Action
Per FDA guidance
Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to complaints@owens-minor.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL, MD, OH, PA, TX, WA
Page updated: Jan 10, 2026