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.
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 2/5 (Moderate).
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.
- Manufacturer
- A & D Enginering Inc
- Hazard
- Affected units
- 378
Distribution
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