Reported Mar 12, 2025 · Ongoing

CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

Kung Shin Plastics Co. Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Kung Shin Plastics Co. Ltd. · 65-2 Erh Chia Road · Taipei Hsien · N/A

Is this the product you have?

  • CircuitGuard Bacterial/Viral Filter
  • with Elbow (Model/Catalogue numberSK200FPE / 7056)
Lot codes and dates
  • UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
Amount recalled
30000 ea/ 300 cases

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • IL

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.