Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 12, 2025
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
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 unabl…
Kung Shin Plastics Co. Ltd. recalled CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filt… - a moderate-severity action.
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filt… was recalled by Kung Shin Plastics Co. Ltd. in March 12, 2025. Reason: The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The is…. Check the official notice for the remedy. Verify recall #Z-1268-2025 with the FDA Devices before acting.
The recall
Kung Shin Plastics Co. Ltd. issued this moderate-severity FDA Devices recall-The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The is….
- Moderate
- severity level
- Class II
- classification
- March 12, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1268-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1268-2025) was formally reported on March 12, 2025, with the manufacturer initiating the action on January 9, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Kung Shin Plastics Co. Ltd. is listed as the recalling firm, operating out of Taipei Hsien. Federal records list the affected scope as 50000 ea/ 500 cases.
The documented reason for this recall is: 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 man… Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of IL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
50000 ea/ 500 cases
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1268-2025 |
| Date reported | March 12, 2025 |
| Date initiated | January 9, 2025 |
| Recalling firm | Kung Shin Plastics Co. Ltd. |
| Firm location | Taipei Hsien |
| Affected scope | 50000 ea/ 500 cases |
| Distribution | US Nationwide distribution in the state of IL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1268-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126). Recalled by Kung Shin Plastics Co. Ltd.. Units affected: 50000 ea/ 500 cases.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2025. Severity: Moderate. Recall number: Z-1268-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of IL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1268-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 12, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.