# FDA recall Z-1082-2024

> **Windstone Medical Packaging, Inc.** · Class I · device recall initiated 2023-12-22.

## Product

Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO

## Reason for recall

Sterility assurance for saline included in surgical kits cannot be guaranteed.

## Distribution

US:  FL, IL, CA OUS: None

## Key facts

- **Recall number:** Z-1082-2024
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-22
- **Report date:** 2024-02-28

- **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-1082-2024

## Citation

> AI Analytics. FDA recall Z-1082-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1082-2024. Source: US FDA. Licensed CC0.

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