# FDA recall Z-1620-2023

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2023-04-24.

## Product

Aligned Medical Solutions Minor Hand Pack,  REF: AMS6539E, containing  P 2 Cover Light Handle Blue STE, Sterile EO

## Reason for recall

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

## Distribution

US: MA OUS: None

## Key facts

- **Recall number:** Z-1620-2023
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-24
- **Report date:** 2023-05-31

- **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-1620-2023

## Citation

> AI Analytics. FDA recall Z-1620-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1620-2023. Source: US FDA. Licensed CC0.

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