The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2812-2026·Announced 2026-08-05

Medical Convenience Kits Recalled Due to Supplier Quality Issue with Lidocaine Injection

Windstone Medical Packaging is recalling 15 AMS spinal convenience kits, lot 230451, 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 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 with no reported injuries in the source; the product is an injectable medication kit, so the High rubric criterion for risk-of-harm products where injury has not yet been reported applies.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 15 AMS Aligned Medical Solutions medical convenience kits labeled as SPINAL KIT, Part Number AMS13683A. The affected kits are identified by UDI/DI B098AMS13683A0 and Lot Number 230451. The kits were distributed nationwide in 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. recalled due to supplier quality issues. The FDA has classified this recall as Class II.

The recall applies only to the specific lot listed above. Consumers can identify affected kits by matching the UDI/DI and lot number. The recall notice does not include additional consumer instructions.

The recalled product

Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Spinal Convenience Kit
Hazard
Affected units
15

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 B098AMS13683A0
  • Lot Number 230451

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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