DEWEI MEDICAL EQUIPMENT CO LTD: Medical Device Recall in 2022 - (Recall #: Z-0323-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

Product Classification:

Class I

Date Initiated: August 9, 2022

Date Posted: December 14, 2022

Recall Number: Z-0323-2023

Event ID: 91137

Reason for Recall:

Products were distributed in the United States without FDA authorization or clearance.

Status: Ongoing

Product Quantity: 1,348,000 (US)

Code Information:

LOT / EXP DW200628 27-Jun-21 DW200520 19-May-21 DW200520 19-May-21 DW201202 01-Dec-21 DW201202 1-Dec-21 DW210103 2-Dec-22 DW210926 25-Sep-22

Distribution Pattern:

US Distribution in states to: CA, FL, KY, and MI.

Voluntary or Mandated:

Voluntary: Firm initiated