FDAClass II · Medical device · Recalled June 10, 2026

Aligned Medical AMS16835 Fluids Kit RX recall — Windstone Medical Packaging, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2307-2026
Brand: Windstone Medical Packaging
Classification: Class II
Units affected: 875 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Aligned Medical AMS16835 Fluids Kit RX

Affected products

Aligned Medical AMS16835 Fluids Kit RX

Companies & origin

Recalling firm location: Billings, MT, United States
Firm address: 1602 4th Ave N, 59101-1521

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Distribution: US Nationwide distribution in the states of IL, VA.
Firm notified the public via: Letter
FDA event ID: 98957
Recall initiated: April 27, 2026
FDA classified: June 3, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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