Aligned Medical AMS16835 Fluids Kit RX recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIOngoing
Summary: Windstone Medical Packaging, Inc. is recalling 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.
What is being recalled
Aligned Medical AMS16835 Fluids Kit RX
Why
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of IL, VA. (states named: Illinois, Virginia)
How to tell if yours is affected
UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2307-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 27, 2026 |
| Reported | June 10, 2026 |
| Company | Windstone Medical Packaging, Inc. |
| Company location | Billings, MT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 875 kits |
More recalls from Windstone Medical Packaging, Inc. · all medical device recalls · recalls from April 2026