Hearth Record

ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for…

Medical device recall Z-2324-2024. Published in FDA’s Enforcement Report on Jul 17, 2024.

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 Jul 17, 2024. 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?

G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest

Source:

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

Which ones are recalled?

ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-00A-TSO G5S-00C G5S-01A G5S-02A G5S-02C G5S-02-L G5S-04A G5S-05A G5S-05C G5S-06A G5S-06C G5S-08A G5S-08C G5S-10A G5S-10C G5S-11A G5S-11C G5S-12C G5S-13A G5S-14A G5S-15A G5S-17A G5S-17C G5S-19A G5S-23C G5S-29A G5S-29C G5S-31A G5S-31A-SJA G5S-31C-SJA G5S-36A G5S-37A G5S-41A G5S-41C G5S-80A G5S-80A-TSO G5S-80C G5S-80-L G5S-82A G5S-82C G5S-83C G5S-90C

14885, in FDA’s words.

Source:

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

Codes to check against yours

GTIN: 00812394021239 00812394021277 00812394021284 00812394021413 00812394022779 00847946038182 00847946038199 00847946038243 00847946038250 00847946038304 00847946038328 00847946038335 00847946038342 00847946038359 00847946038380…

Every code shown here, 532 characters

GTIN: 00812394021239 00812394021277 00812394021284 00812394021413 00812394022779 00847946038182 00847946038199 00847946038243 00847946038250 00847946038304 00847946038328 00847946038335 00847946038342 00847946038359 00847946038380 00847946038397 00847946038403 00847946038410 00847946038434 00847946038441 00847946038496 00847946038519 00847946038533 00847946038571 00847946038588 00847946038663 00847946038816 00847946038830 00847946039028 00847946039035 00847946039066 00847946039127 Serial Number Range: D00000276194-D00000343449

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.

Nationwide including PR. Foreign: AU BM CA CH DE DK ES FR GB HK HU ID IE IL IT KR MA MT NL NO PR SA SE SI SN TR

The states and territories these words name

  • Puerto Rico

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.

Source:

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.

Source:

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

  • The firm began the recall on May 31, 2024.
  • FDA classified it on Jul 10, 2024.
  • FDA’s Enforcement Report published it on Jul 17, 2024.
Source:

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

Who is recalling it?

  • Zoll Medical Corporation, of Deerfield, WI.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: E-Mail.
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.”
  • 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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