The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2819-2026·Announced 2026-08-05

Medical Convenience Kits Recalled Over Lidocaine Injection Supplier Quality Issues

Windstone Medical Packaging is recalling 15 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues reported by Elevaris Medical Devices Inc.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving medical devices with supplier quality issues affecting lidocaine injections. Per the rubric, FDA Class II recalls with potential for temporary or medically reversible adverse health consequences warrant a severity score of 4 (Severe).

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 15 units of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Port Tray - RX, Part Number 008786-19. These kits contain Elevaris Lidocaine HCl injection USP, which was recalled by Elevaris Medical Devices Inc. due to supplier quality issues.

The recalled kits have UDI/DI code B098008786190 and Lot Number 230451. They were distributed nationwide 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 initiated because the Lidocaine HCl injection USP included in these convenience kits was found to have supplier quality issues, as reported by Elevaris Medical Devices Inc. This is a Class II recall, meaning use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and consumers who received the affected kits should stop using them immediately and contact Windstone Medical Packaging, Inc. for return or replacement instructions. Any adverse reactions or quality issues should be reported to the FDA.

The recalled product

Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Convenience Kit with Lidocaine Injection
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 B098008786190
  • Lot Numbers: 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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