FDA Enforcement
Class II
Ongoing
Aligned Medical AMS16835 Fluids Kit RX
Recall: Z-2307-2026
·
Reported June 10, 2026
Enforcement
- Recall Number
- Z-2307-2026
- Event ID
- 98957
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Windstone Medical Packaging, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 10, 2026
- Initiation Date
- April 27, 2026
- Classification Date
- June 3, 2026
- Address
- 1602 4th Ave N, Billings, MT, 59101-1521, United States
Description
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.
Code Info
UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Distribution
US Nationwide distribution in the states of IL, VA.
Quantity
875 kits