CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
CircuitGuard Bacterial/Viral Filter with Elbow recalled
Kung Shin Plastics is recalling CircuitGuard Bacterial/Viral Filter with Elbow (, distributed nationwide in the US. The recall was initiated on 9 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1269-2025
- FDA event ID
- 96224
- Recalling firm
- Kung Shin Plastics, Taipei Hsien
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2025
- FDA classified
- 4 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2025 | Recall initiated by company | |
| 4 Mar 2025 | Classified by FDA | +54 days |
| 12 Mar 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Where it was distributed
US Nationwide distribution in the state of IL.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
Where was it sold?
US Nationwide distribution in the state of IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96224| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CircuitGuard ThermoFlo Filter -Combined Heat recalled | Kung Shin Plastics | Foreign Material | Nationwide |
More recalls from Kung Shin Plastics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CircuitGuard ThermoFlo Filter -Combined Heat recalled | Kung Shin Plastics | Foreign Material | Nationwide |
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