The FDA has posted 6 enforcement recalls of over the counter blood glucose test system devices since 2025, including 4 Class I (most serious) recalls. Most recent report: Mar 18, 2026.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System..…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“System, Test, Blood Glucose, Over The Counter”). Informational only — verify against the FDA before acting.