The Recall Desk
ModerateFDA (Devices)·Z-2818-2026·Announced 2026-08-05

Medical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue

Windstone Medical Packaging is recalling 3,378 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP because the lidocaine was recalled due to supplier quality issues.

What this means for you

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 source does not report hospitalizations, injuries, or deaths. This matches the Moderate criterion rather than Severe, which requires Class II with hospitalization reports.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 3,378 AMS Aligned Medical Solutions medical convenience kits. The affected products are 23 convenience kit part numbers, including Loop Recorder Pack 2 -RX, NY Tray - RX, NYC Tray - RX, Vein Pack - RX, Radiology Tray-RX, Custom Pack - RX, Biopsy Tray w/Lidocaine - RX, Arthrogram Tray - RX, Myelogram Tray - RX, Pain Pack -RX, Pain Tray -RX, Vasectomy Pack - RX, Basic Procedure Pack - RX, Basic Pack - RX, Supply Kit - RX, and Maximal Sterile Barrier Vascular Access Procedure Kit - RX, among others. Specific lot numbers are listed in the FDA recall notice for each part number.

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 action as Class II. The source does not describe the specific supplier quality issue or any reported injuries.

The kits were distributed nationwide in the United States, including Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia, and Washington.

The recall notice does not provide specific consumer instructions. Users and facilities with affected kits should check the part number and lot number against the recall notice and contact Windstone Medical Packaging, Inc. for further guidance.

The recalled product

Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part N
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Medical Convenience Kit
Hazard
Affected units
3,378

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 (20)

  • Part Number AMS10164
  • UDI/DI B098AMS101640
  • Lot Numbers: 230816
  • Part Number AMS10276A
  • UDI/DI B098AMS10276A0
  • Lot Numbers: 230588
  • 230589
  • 230590
  • 230893
  • 241165
  • Part Number AMS10281B
  • UDI/DI B098AMS10281B0
  • Lot Numbers: 215784
  • 231259
  • 241171
  • Part Number AMS11398C
  • UDI/DI B098AMS11398C0
  • Lot Numbers: 230680
  • Part Number AMS1217A
  • UDI/DI B098AMS1217A0

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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Same manufacturer · Windstone Medical Packaging, Inc.

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