Class II U.S. Food and Drug Administration

Windstone Medical Packaging, Inc. AMS Aligned Medical Solutions medical convenience recall: Windstone Medical Packaging recalled specific items and lots of AMS

Recall published 3 months ago

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2815-2026
Published
August 5, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Windstone Medical Packaging, Inc.
Product type
Medical devices
Units affected
60 kits
Distribution
Nationwide
Made in
United States
Lot / code info
UDI/DI B098AMS94610, Lot Numbers: 230658, 231173.

Products covered by this recall

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 230658
  • 231173. — 60 kits

Model or item number

On the rating label, the box or the instruction sheet.

  • AMS9461 — UDI
  • DI B098AMS94610

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Windstone Medical Packaging, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Windstone Medical Packaging, Inc. — 1602 4th Ave N, Billings, MT, 59101-1521

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Windstone Medical Packaging, Inc. medical devices recalled?

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 230658, 231173. — 60 kits; model number AMS9461 — UDI, DI B098AMS94610. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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