Severity
Moderate
The recall
Wuxi Medical lnstrument Factory Co., Ltd. issued this moderate-severity FDA Drug recall — Lack of assurance of sterility and cGMP deviations observed at the manufacturing site..
Sourced from official FDA Drug enforcement records. Verify recall #D-0247-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0247-2025) was formally reported on March 5, 2025, with the manufacturer initiating the action on February 12, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Wuxi Medical lnstrument Factory Co., Ltd. is listed as the recalling firm, operating out of Wuxi, N/A. Federal records indicate 37,500 Boxes units are affected.
The documented reason for this recall is: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. Distribution data in the federal record shows the product reached: FL. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Severity
Moderate
Units Affected
37,500 Boxes
Related Recalls
6
0 from same agency
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.
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0247-2025 |
| Date reported | March 5, 2025 |
| Date initiated | February 12, 2025 |
| Recalling firm | Wuxi Medical lnstrument Factory Co., Ltd. |
| Units affected | 37,500 Boxes |
| Distribution | FL |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported March 5, 2025.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).