FDA Medical devices recall ·
Aligned Medical AMS16835 Fluids Kit RX recall
- Recall number
- Z-2307-2026
- Date
- (initiated April 27, 2026)
- Company / brand
- Windstone Medical Packaging, Inc.
1602 4th Ave N, Billings, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 875 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Aligned Medical AMS16835 Fluids Kit RX
Why was it recalled?
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Distribution
US Nationwide distribution in the states of IL, VA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2307-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.