---
title: "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) RO... — FDA record Z-2471-2025 | Is It on Recall"
description: "During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are"
url: https://isitonrecall.com/recall/fda-device-z-2471-2025-american-contract-systems-medical-procedure-kits-and-trays-labeled-as-1-robot-hyst-pack-model-item-n/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E... — FDA record Z-2471-2025

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 Jul 14, 2025. 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**: AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
- **Reason**: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- **Classification**: Class II
- **Recalling firm**: American Contract Systems Inc
- **Quantity**: 50 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2471-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2471-2025%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 | 1) MODEL/ITEM NUMBER GRRB10E: UDI/DI 00191072236371, Kit Lot Numbers: 42-8157011, 42-8126811; 2) MODEL/ITEM NUMBER SPVH62P: UDI/DI 00191072238771, Kit Lot Numbers: 12-7322911, 12-7384911. |

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

## Distribution

US distribution to states of: IL and LA

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

- [Illinois](https://isitonrecall.com/state/illinois/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)

## Dates in the source

- **Report date**: Sep 3, 2025
- **Recall initiation date**: Jul 14, 2025
- **Center classification date**: Aug 28, 2025

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-2471-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [American Contract Systems, Inc. records](https://isitonrecall.com/brand/american-contract-systems-inc/)