# FDA recall Z-2307-2026

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2026-04-27.

## Product

Aligned Medical AMS16835 Fluids Kit   RX

## Reason for recall

Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

## Distribution

US Nationwide distribution in the states of IL, VA.

## Key facts

- **Recall number:** Z-2307-2026
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-27
- **Report date:** 2026-06-10

- **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-2307-2026

## Citation

> MORVS. FDA recall Z-2307-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-2307-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*