Hearth Record

Blood Pressure Monitor UA-767PBT-Ci for small cuff

Medical device recall Z-0063-2017. Published in FDA’s Enforcement Report on Oct 19, 2016.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Oct 19, 2016. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“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.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

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.

378 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Serial numbers: 5150100209 5150100207 5150100204 5150100203 5150100210 5150301449 5150301448 5150301444 5150301445 5150301446 5150301443 5150301450 5150301441 5150301442 5150301447 5150402687 5150402720 5150402711 5150402729 5150402714…

Every code shown here, 1,996 characters

Serial numbers: 5150100209 5150100207 5150100204 5150100203 5150100210 5150301449 5150301448 5150301444 5150301445 5150301446 5150301443 5150301450 5150301441 5150301442 5150301447 5150402687 5150402720 5150402711 5150402729 5150402714 5150402830 5150402810 5150402826 5150402839 5150402730 5150402835 5150402716 5150402762 5150402769 5150402768 5150402834 5150402726 5150402832 5150402809 5150402829 5150402764 5150402823 5150402760 5150402806 5150402787 5150402756 5150402784 5150402761 5150402783 5150402801 5150402821 5150402802 5150402805 5150402833 5150402824 5150402838 5150402649 5150402827 5150402650 5150402804 5150402757 5150402685 5150402763 5150402770 5150402790 5150402645 5150402755 5150402715 5150402782 5150402789 5150402753 5150402807 5150402644 5150402803 5150402688 5150402767 5150402786 5150402686 5150402721 5150402713 5150402682 5150402728 5150402717 5150402723 5150402689 5150402712 5150402752 5150402727 5150402725 5150402648 5150402684 5150402690 5150402642 5150402647 5150402683 5150402719 5150402759 5150402766 5150402751 5150402681 5150402754 5150402765 5150402722 5150402724 5150402758 5150402643 5150402718 5150402641 5150402788 5150402837 5150402828 5150402646 5150402840 5150402836 5150402808 5150402781 5150402822 5150402785 5150402825 5150402831 5150200109 5150200108 5150200469 5150200468 5150200102 5150200242 5150200103 5150200529 5150200522 5150200526 5150200525 5150200467 5150200523 5150200521 5150200528 5150200527 5150200465 5150200341 5150200463 5150200106 5150200342 5150200105 5150200343 5150200345 5150200347 5150200349 5150200241 5150200247 5150200243 5150200244 5150200246 5150200248 5150200249 5150200250 5150200245 5150200348 5150200346 5150200350 5150200344 5150200107 5150200524 5150200464 5150200470 5150200461 5150200462 5150200466 5150200530 5150200104 5150200110 5150200101 5150100992 5150100997 5150100994 5150100993 5150100999 5150101126 5150101122 5150100991 5150100995 5150101123 5150100998 5150101128 5150101125 5150101127 5150100996…

FDA’s list runs to 4,175 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

to distributors in NY, MA, VA. TX,

The states and territories these words name

  • Massachusetts
  • New York
  • Texas
  • Virginia
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Sep 12, 2016.
  • FDA classified it on Oct 9, 2016.
  • FDA’s Enforcement Report published it on Oct 19, 2016.
  • FDA terminated it on Aug 28, 2018.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • A & D Enginering Inc, of San Jose, CA.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • FDA’s list of codes runs to 4,175 characters; the first part is shown here, and the rest is on FDA’s record.
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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