Recall Z-2307-2026— Windstone Medical Packaging, Inc.
Class II · Ongoing
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2026-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Aligned Medical AMS16835 Fluids Kit RX. Reason: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-27
- Firm location
- Billings, MT, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.