The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1254-2022·Announced 2022-06-15

MedMinder Medication Dispenser Emergency Alert Function No Longer Operational

MedMinder Medication Dispensers will no longer connect to the emergency alert system for all models. The device's emergency communication capability has been discontinued for approximately 2,701 units nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall affecting the device's core emergency communication feature, with no reported illnesses or injuries. Loss of emergency alert connectivity for a product designed for vulnerable users represents a risk of harm.

Plain-English summary

MedMinder Medication Dispensers are recalled because the Emergency Alert watch or pendant will no longer connect to the emergency alert system. This affects all models of the device and removes the emergency communication capability.

Approximately 2,701 units are distributed nationwide. The devices, designed to promote medication adherence and communicate with emergency call centers, can no longer fulfill the emergency alert function. The medical alert button feature on older models without screens is also being removed.

Consumers should immediately stop relying on the emergency alert function and use alternative methods to contact emergency services. Contact Medminder Systems, Inc. for information about remediation options or device replacement.

The recalled product

Product
MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.
Affected units
2,701

Distribution

Distributed nationwide across the United States.

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