# FDA recall Z-1268-2025

> **Kung Shin Plastics Co. Ltd.** · Class II · device recall initiated 2025-01-09.

## Product

CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

## Reason for recall

The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

## Distribution

US Nationwide distribution in the state of IL.

## Key facts

- **Recall number:** Z-1268-2025
- **Recalling firm:** Kung Shin Plastics Co. Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-09
- **Report date:** 2025-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Taipei Hsien, Taiwan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2025

## Citation

> AI Analytics. FDA recall Z-1268-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1268-2025. Source: US FDA. Licensed CC0.

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