FDAClass IIJune 10, 2026

Aligned Medical AMS16835 Fluids Kit recall

Aligned Medical AMS16835 Fluids Kit RX

Why was Aligned Medical AMS16835 Fluids Kit recalled?

Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

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?

UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935

Product
Aligned Medical AMS16835 Fluids Kit RX
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
875 kits
Distribution
US Nationwide distribution in the states of IL, VA.
Recall date
June 10, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls