CircuitGuard Bacterial/Viral Filter with Elbow — Class II medical device recall Z-1269-2025
Ongoing recall by Kung Shin Plastics Co. Ltd., reported 2025-03-12, distributed nationwide. The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The iss
| Recall number | Z-1269-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kung Shin Plastics Co. Ltd., Taipei Hsien, Taiwan |
| Recall initiated | 2025-01-09 |
| Classified | 2025-03-04 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00810050853682 |
| Lot numbers | C2N24002 |
| Model numbers | 7056, SK200FPE |
Product
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1269-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.