# FDA recall Z-1313-2024

> **Mckesson Medical-Surgical Inc. Corporate Office** · Class II · device recall initiated 2024-01-09.

## Product

Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

## Reason for recall

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

## Distribution

US Nationwide distribution in the states of AZ, PA and TX.

## Key facts

- **Recall number:** Z-1313-2024
- **Recalling firm:** Mckesson Medical-Surgical Inc. Corporate Office
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-09
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2024

## Citation

> AI Analytics. FDA recall Z-1313-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1313-2024. Source: US FDA. Licensed CC0.

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