# FDA recall Z-2813-2026

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

## Product

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)	Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ;   2)	Single Shot Epidural Tray - RX, Part Number AMS11296A;   3)	Nerve Block Tray - RX, Part Number AMS11314A;   4)	Epidural Tray - RX, Part Number AMS11910A;   5)	Nerve Block Tray - RX, Part Number AMS12171;   6)	Single Shot Epidural Tray - RX, Part Number AMS12219A;   7)     Universal Block Tray - RX, Part Number AMS12381B.

## 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-2813-2026
- **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-2813-2026

## Citation

> AI Analytics. FDA recall Z-2813-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2813-2026. Source: US FDA. Licensed CC0.

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