# FDA recall Z-2640-2023

> **3M Company - Health Care Business** · Class II · device recall initiated 2023-08-22.

## Product

3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes

## Reason for recall

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.

## Key facts

- **Recall number:** Z-2640-2023
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-22
- **Report date:** 2023-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2023

## Citation

> AI Analytics. FDA recall Z-2640-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2640-2023. Source: US FDA. Licensed CC0.

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