ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate…
Medical device recall Z-1931-2019. Published in FDA’s Enforcement Report on Jul 10, 2019.
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 Jul 10, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1,969 how much, in FDA’s words
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is a potential for the device to fail to deliver energy to the patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.
1,969, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Numbers: 90010200499991010, 90010400499991010, 70010400499991010, 90010202499991010, 90010600499991010; GTIN: 00847946016128, 00847946016142, 00847946015138, 00847946016135, 00847946016166 Serial Numbers: AA17C041915 AA17C041916…
Every code shown here, 1,998 characters
Part Numbers: 90010200499991010, 90010400499991010, 70010400499991010, 90010202499991010, 90010600499991010; GTIN: 00847946016128, 00847946016142, 00847946015138, 00847946016135, 00847946016166 Serial Numbers: AA17C041915 AA17C041916 AA17J043664 AA17J043666 AA17J043670 AA17J043671 AA17J043672 AA17J043673 AA17J043674 AA17J043675 AA17J043682 AA17J043683 AA17J043725 AA17J043813 AA17J043814 AA17J043817 AA17J043820 AA17J043825 AA17L044265 AA18B044867 AA18B044868 AA18B044869 AA18B044870 AA18B044871 AA18B044872 AA18B044873 AA18B044874 AA18B044875 AA18B044877 AA18B044878 AA18B044879 AA18B044880 AA18B044881 AA18B044882 AA18B044883 AA18B044884 AA18B044885 AA18B044886 AA18C044887 AA18C044888 AA18C044889 AA18C044890 AA18C044891 AA18C044892 AA18C044893 AA18C044894 AA18C044895 AA18C044896 AA18C044897 AA18C044898 AA18C044899 AA18C044900 AA18C044901 AA18C044902 AA18C044903 AA18C044904 AA18C044905 AA18C044906 AA18C044907 AA18C044908 AA18C044909 AA18C044910 AA18C044911 AA18C045011 AA18C045012 AA18C045013 AA18C045014 AA18C045015 AA18C045016 AA18C045017 AA18C045018 AA18C045019 AA18C045020 AA18C045021 AA18C045022 AA18C045023 AA18C045024 AA18C045025 AA18C045026 AA18C045027 AA18C045028 AA18C045029 AA18C045030 AA18C045031 AA18C045032 AA18C045033 AA18C045034 AA18C045035 AA18C045036 AA18C045037 AA18C045038 AA18C045039 AA18C045040 AA18C045041 AA18C045042 AA18C045043 AA18C045044 AA18C045045 AA18C045046 AA18C045047 AA18C045048 AA18C045049 AA18C045050 AA18C045051 AA18C045052 AA18C045053 AA18C045054 AA18C045055 AA18C045056 AA18C045057 AA18C045058 AA18C045059 AA18C045060 AA18C045061 AA18C045062 AA18C045063 AA18C045064 AA18C045065 AA18C045070 AA18C045071 AA18C045072 AA18C045073 AA18C045074 AA18C045075 AA18C045076 AA18C045077 AA18C045078 AA18C045079 AA18C045080 AA18C045081 AA18C045082 AA18C045083 AA18C045084 AA18C045085 AA18C045086 AA18C045087 AA18C045088 AA18C045089 AA18C045090 AA18C045091 AA18C045092 AA18C045093 AA18C045094 AA18C045095 AA18C045096 AA18C045097 AA18C045098 AA18C045099 AA18C045100…
FDA’s list runs to 23,837 characters. The first part is shown; the rest is on FDA’s record.
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.
Worldwide Distribution - US nationwide. The products were distributed to the following foreign countries: Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, Italy, Japan, Luxemburg, New Zealand, Panama, Russia, Saudi Arabia, Singapore, Spain, Thailand, Taiwan.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 12, 2019.
- FDA classified it on Jul 3, 2019.
- FDA’s Enforcement Report published it on Jul 10, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ZOLL Medical Corporation, of Chelmsford, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 23,837 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.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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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.
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.