# FDA recall Z-1609-2023

> **3M Company - Health Care Business** · Class II · device recall initiated 2023-04-06.

## Product

3M Attest Steam Chemical Integrators, REF 1243A

## Reason for recall

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

## Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Australia, Bolivia, Brazil, Canada, Colombia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Vietnam.

## Key facts

- **Recall number:** Z-1609-2023
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-06
- **Report date:** 2023-05-24

- **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-1609-2023

## Citation

> AI Analytics. FDA recall Z-1609-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1609-2023. Source: US FDA. Licensed CC0.

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