Windstone Medical Packaging, Inc.: General Surgery Tray

Windstone Medical Packaging, Inc. is recalling the Aligned Medical AMS16835 Fluids Kit, a surgical tray used in general surgery procedures, because it contains Lidocaine Hydrochloride Injection that was previously recalled by its supplier due to quality concerns. The product was distributed nationwide across the US. This is a Class II recall, meaning use of the product could cause serious harm or adverse health effects.

Recalling firm
Windstone Medical Packaging, Inc.
Product
Aligned Medical AMS16835 Fluids Kit RX
Reason
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-04-27
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution in the states of IL, VA.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4c01b4eb-e3dd-46a8-8c33-a0c6868f5c61