Agency classClass IIOur severity:High FDA (Devices)·Z-2307-2026·Announced 2026-06-10

Aligned Medical fluids kits contain recalled lidocaine injection

Aligned Medical AMS16835 Fluids Kits are being recalled because they include Lidocaine Hydrochloride Injection, USP that was recalled by a supplier for quality issues.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where kits were shipped containing a drug subsequently recalled for quality issues, a risk of harm with no injuries reported.

Plain-English summary

The Aligned Medical AMS16835 Fluids Kit, UDI-DI B098AMS168350, is being recalled. The action covers 875 kits across lots 233828, 236048, 236359, 236662, 238580, 239934 and 239935.

The stated reason is that Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in these custom convenience kits. The FDA classified the action as Class II.

Distribution was within the United States, in Illinois and Virginia. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected kits using the UDI-DI and lot numbers above, quarantine them, and follow the instructions issued by the manufacturer.

The recalled product

Product: Aligned Medical AMS16835 Fluids Kit RX
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Procedure kit
Hazard: contained-drug-recall
quality-issues
class-ii
convenience-kit
Affected units: 875

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

UDI-DI: B098AMS168350
Lot Numbers: 233828
236048
236359
236662
238580
239934
239935

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Windstone Medical Packaging, Inc.

See all →

High
Windstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
Moderate
AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
High
Medical convenience kits recalled due to potential endotoxin level variability
FDA (Devices) · 2026-08-05
Moderate
Medical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
Moderate
Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05

Same hazard · contained drug recall