FDA DevicesClass II
Aligned Medical AMS16835 Fluids Kit RX
Published: June 10, 2026Recall ID: Z-2307-2026Category: devicesCountry: US
Reason for Recall / Hazard
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Product Description & Identification
Aligned Medical AMS16835 Fluids Kit RX
Affected Products
Aligned Medical AMS16835 Fluids Kit RX
Additional Source Details
| Field | Value |
|---|---|
| City | Billings |
| State | MT |
| Event id | 98957 |
| Address 1 | 1602 4th Ave N |
| Code info | UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935 |
| Postal code | 59101-1521 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 875 kits |
| Reason for recall | Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Letter |
| Center classification date | 20260603 |
Overview
- Recalling FirmWindstone Medical Packaging, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of IL, VA.