CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report

CircuitGuard ThermoFlo Filter -Combined Heat recalled

Kung Shin Plastics is recalling CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral, 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

Lot, batch or date codesUDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002

Quantity recalled50000 ea/ 500 cases

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-1268-2025
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: E-Mail
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 ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

Where it was distributed

US Nationwide distribution in the state of IL.

Nationwide Illinois

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002

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

This product is part of a recall event; the main page for the event is CircuitGuard Bacterial/Viral Filter with Elbow recalled.

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025	CLASS II	CircuitGuard Bacterial/Viral Filter with Elbow recalled	Kung Shin Plastics	Foreign Material	Nationwide

More recalls from Kung Shin Plastics

All 2

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Device	CLASS II	CircuitGuard Bacterial/Viral Filter with Elbow recalled	Kung Shin Plastics	Foreign Material	Nationwide

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