FDAClass IIAugust 13, 2025

GS ENDOSCOPY PACK. Medical convenience kit recall

GS ENDOSCOPY PACK. Medical convenience kit.

Why was GS ENDOSCOPY PACK. Medical convenience kit recalled?

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
GS ENDOSCOPY PACK. Medical convenience kit.
Recalling firm
AVID Medical, Inc.
Quantity
816 units
Distribution
Domestic: CA, IL, MD, OH, PA, TX, WA.
Recall date
August 13, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls