FDA Recall D-0247-2025

Wuxi Medical lnstrument Factory Co., Ltd. · Wuxi, N/A

Class II Ongoing 456 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

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

Quantity: 37,500 Boxes

Reason for recall

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

Recall record

Recall number: D-0247-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: FL
Recall initiated: 2025-02-12
Classified by FDA Center: 2025-02-21
FDA published: 2025-03-05
Recalling firm: Wuxi Medical lnstrument Factory Co., Ltd.
Firm location: Wuxi, N/A, China

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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