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All product recalls associated with General Electric Med Systems LLC.
Total Recalls
1000
Past Year
1000
Class I (Serious)
34
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.