← FDA ENFORCEMENT
D-0247-2025Class II

Wuxi Medical lnstrument Factory Co., Ltd.

Recalling firm
Wuxi Medical lnstrument Factory Co., Ltd.
Product type
Drug
Status
Ongoing
Report date
2025-03-05
Distribution
FL
Firm state
N/A
Product quantity
37,500 Boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Product description

ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.

Code / lot info

Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.

Other recalls SPEQ maps to Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.