The Recall Desk
ModerateFDA (Devices)·Z-0063-2017·Announced 2016-10-19

A&D Blood Pressure Monitors Recalled for Small Cuff Labeling Error

A&D Engineering is recalling 378 blood pressure monitors that were not labeled for use with small cuffs. The devices were distributed to distributors in New York, Massachusetts, Virginia, and Texas.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the issue is a labeling error regarding cuff size. There are no reports of illness or injury, and the hazard is related to potential misuse rather than a direct safety defect like a structural failure.

Plain-English summary

A&D Engineering Inc. is recalling 378 units of the Blood Pressure Monitor UA-767PBT-Ci for small cuff. The recall was initiated because the devices may have been shipped without proper labeling indicating they are designed for use with small cuffs. The product is intended for end users aged 18 and older to monitor blood pressure and pulse rate at home.

The affected units were distributed to distributors in New York, Massachusetts, Virginia, and Texas. The recall notice does not specify the exact number of units sold to consumers or the specific dates of distribution.

Consumers with affected devices should stop using them and contact A&D Engineering for instructions on how to proceed. The recall is limited to the specific serial numbers listed in the official FDA record Z-0063-2017.

The recalled product

Product
Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.
Affected units
378

Distribution

Distributed in 3 states: