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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.

Jul 18, 2022 Other Medical Devices Nationwide View Details →
Class I - Dangerous

SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.

Jul 14, 2022 Other Medical Devices Nationwide View Details →

The product falls apart during handling after removal from its primary packaging.

Jun 22, 2022 Surgical Instruments Nationwide View Details →

Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).

Jun 24, 2022 Diagnostic Equipment Nationwide View Details →