The Recall Desk

Manufacturer

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

3 recalls in our database name FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2024-10-09

Of the 3 recalls from FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-3308-2024·2024-10-09

    DVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization

    DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.

    Product
    DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3306-2024·2024-10-09

    DVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization

    The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.

    Product
    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3307-2024·2024-10-09

    DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization

    The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.

    Product
    DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
    Category
    Medical Device
    Distribution
    0 states