FDAFDA · Food and drugs·Recall number Z-2307-2026
Aligned Medical AMS16835 Fluids Kit RX
Published June 10, 2026 · Recall initiated: April 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- US Nationwide distribution in the states of IL, VA.
- Lot
- UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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