FDA recall Z-2307-2026

Windstone Medical Packaging, Inc. · Class II · device

Product

Aligned Medical AMS16835 Fluids Kit RX

Reason for recall

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

Distribution

US Nationwide distribution in the states of IL, VA.

Key facts

Status
Ongoing
Initiation date
2026-04-27
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2307-2026