# FDA recall Z-2641-2024

> **Microtek Medical Inc.** · Class II · device recall initiated 2024-06-03.

## Product

Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

## Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

## Distribution

Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

## Key facts

- **Recall number:** Z-2641-2024
- **Recalling firm:** Microtek Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-03
- **Report date:** 2024-08-28

- **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-2641-2024

## Citation

> AI Analytics. FDA recall Z-2641-2024. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2641-2024. Source: US FDA. Licensed CC0.

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