Class II

Medical Device Recall: Aligned Medical AMS16835 Fluids Kit RX

Windstone Medical Packaging, Inc. · April 27, 2026

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.

States Affected

NATIONWIDE

Quantity Affected

875 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2307-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.