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.

Windstone Medical Packaging, Inc. Medical Device Recall: Aligned Medical AMS16835 Fluids Kit RX | SafeCheck