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Aligned Medical AMS16835 Fluids Kit RX

Class II
Recalling firm
Windstone Medical Packaging, Inc.
Reason for recall
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Affected products (lot / model / serial)
UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Units affected
875 kits
Distribution pattern
US Nationwide distribution in the states of IL, VA.
Firm location
Billings, MT, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2307-2026
Recall initiated
April 27, 2026
FDA classification date
June 3, 2026
FDA report date
June 10, 2026
FDA event ID
98957
Last updated on HTM Vibe
July 23, 2026
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