The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2817-2026·Announced 2026-08-05

Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues

Windstone Medical Packaging is recalling 100 AMS convenience kits labeled Block Tray - RX, Part Number AMS12414, because they contain Elevaris Lidocaine HCl injection recalled for supplier 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this recall as Class II, and the notice does not report any illnesses, injuries, or hospitalizations. This aligns with the Moderate severity level under the rubric.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 100 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Block Tray - RX, Part Number AMS12414. The affected kits have UDI/DI B098AMS124140 and Lot Number 230411. The kits were distributed nationwide in the U.S. in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA.

The recall was issued because the kits contain Elevaris Lidocaine HCl injection USP, which Elevaris Medical Devices Inc. previously recalled due to supplier quality issues. The FDA has classified this recall as Class II.

Consumers who have an affected kit should verify the lot number and contact Windstone Medical Packaging, Inc. for further guidance. Healthcare providers and distributors should check their inventory for the recalled lot and follow the recall notice for next steps.

The recalled product

Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Medical Convenience Kit
Hazard
Affected units
100

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 (2)

  • UDI/DI B098AMS124140
  • Lot Numbers: 230411.

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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