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Home › FDA recalls › Aligned Medical AMS16835 Fluids Kit RX
CLASS II · ModerateFDA

Windstone Medical Packaging, Inc. recalls Aligned Medical AMS16835 Fluids Kit RX

📅 Apr 27, 2026 · 📍 Nationwide
Recalling company
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 – may cause temporary or medically reversible health consequences
Recall date
Apr 27, 2026
Reported
Jun 10, 2026
Distribution
US Nationwide distribution in the states of IL, VA.
Status
Ongoing
Quantity
875 kits
Lot / codes
UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Company location
Billings, MT
Recall type
Voluntary: Firm initiated
Recall number
Z-2307-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2307-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.