# FDA recall Z-1909-2025

> **Healthmark Industries Co., Inc.** · Class II · device recall initiated 2025-05-02.

## Product

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

## Reason for recall

During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

## Distribution

US Nationwide and Internationally to countries of: Canada, Malaysia.

## Key facts

- **Recall number:** Z-1909-2025
- **Recalling firm:** Healthmark Industries Co., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-02
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fraser, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1909-2025

## Citation

> AI Analytics. FDA recall Z-1909-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1909-2025. Source: US FDA. Licensed CC0.

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