---
title: "Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Ligh... — FDA record Z-1621-2023 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-1621-2023-aligned-medical-solutions-hand-pack-ref-ams4601e-containing-p-2-cover-light-handle-blue-ste-sterile/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO — FDA record Z-1621-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: Windstone Medical Packaging, Inc.
- **Quantity**: 60 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1621-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1621-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot 188843; UDI: B098AMS4601E0 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: MA OUS: None

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Massachusetts](https://isitonrecall.com/state/massachusetts/)

## Dates in the source

- **Report date**: May 31, 2023
- **Recall initiation date**: Apr 24, 2023
- **Center classification date**: May 23, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1621-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Windstone Medical Packaging, Inc. records](https://isitonrecall.com/brand/windstone-medical-packaging-inc/)