The Recall Desk
HighFDA (Devices)·Z-1269-2025·Announced 2025-03-12

CircuitGuard Bacterial/Viral Filter Recalled for Plastic Connector Obstruction

Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with serious risk of harm through oxygen deprivation and respiratory distress if ventilation fails. No illnesses or injuries are reported in the source text, making this a risk-of-harm situation without confirmed injury, which corresponds to Score 3 (High) per the rubric.

Plain-English summary

Kung Shin Plastics Co. Ltd. is recalling the CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalog number SK200FPE / 7056). Approximately 30,000 units were distributed in the United States in Illinois across 300 cases. The affected lot is C2N24002.

The machine-side connector of the filter may be occluded (blocked) by plastic, which prevents proper airflow. This defect can cause the ventilation bag to malfunction, making it difficult or impossible for users to properly inflate or deflate the bag during manual ventilation.

Users of this filter face potential health risks if the connector obstruction prevents proper ventilation. These risks include oxygen deprivation, respiratory distress, and associated medical complications. The recall was issued by the U.S. Food and Drug Administration as a Class II recall.

The recalled product

Product
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Manufacturer
Kung Shin Plastics Co. Ltd.
Category
Medical Device — Respiratory Filter
Hazard
  • connector-obstruction
  • oxygen-deprivation
  • respiratory-distress

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002

Distribution

Distributed nationwide across the United States.

Related recalls

Same category