# FDA recall Z-2812-2026

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2026-06-17.

## Product

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  SPINAL KIT, Part Number AMS13683A

## Reason for recall

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP.  Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

## Distribution

US Nationwide distribution 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, WA.

## Key facts

- **Recall number:** Z-2812-2026
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-17
- **Report date:** 2026-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billings, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2812-2026

## Citation

> AI Analytics. FDA recall Z-2812-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2812-2026. Source: US FDA. Licensed CC0.

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