DDU-2300 Lifeline/ReviveR View
Medical device recall Z-2392-2020. Published in FDA’s Enforcement Report on Jun 24, 2020.
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 Jun 24, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 860 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?
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
860, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 400086354 400086358 400090005 400091761 400093477 400093478 400093479 400093480 400093481 400093482 400093483 400093484 400093485 400093486 400093487 400093488 400093489 400093490 400093491 400093492 400093493 400093494…
Every code shown here, 1,996 characters
Serial Numbers: 400086354 400086358 400090005 400091761 400093477 400093478 400093479 400093480 400093481 400093482 400093483 400093484 400093485 400093486 400093487 400093488 400093489 400093490 400093491 400093492 400093493 400093494 400093495 400093496 400093497 400093498 400093499 400093500 400093501 400093502 400093503 400093504 400093505 400093506 400093508 400093510 400093512 400093513 400093514 400093515 400093516 400093517 400093518 400093519 400093520 400093521 400093522 400093523 400093524 400093525 400093527 400093528 400093529 400093530 400093531 400093532 400093533 400093534 400093535 400093536 400093538 400093539 400093540 400093541 400093542 400093543 400093544 400093545 400093546 400093547 400093548 400093549 400093550 400093551 400093552 400093553 400093554 400093555 400093556 400093557 400094155 400098786 400098812 400101171 400101172 400101174 400101175 400101176 400101177 400101178 400101179 400101180 400101181 400101182 400101183 400101184 400101185 400101186 400101187 400101188 400101189 400101190 400101191 400101192 400101193 400101194 400101195 400101196 400101197 400101198 400101199 400101200 400101203 400101204 400101205 400101207 400101208 400101209 400101213 400101214 400101217 400101218 400101219 400101220 400101221 400101222 400101223 400101225 400101226 400101227 400101229 400101230 400101231 400101236 400101237 400101238 400101240 400101241 400101242 400101244 400101245 400101246 400101247 400101248 400101250 400101251 400101252 400101253 400101254 400101255 400101256 400101257 400101258 400101259 400101260 400101261 400101262 400101263 400101264 400101265 400101266 400101267 400101268 400101575 400101576 400101577 400101578 400101579 400101580 400101581 400101582 400101583 400101584 400101585 400101587 400101588 400101589 400101590 400101591 400101592 400101593 400101594 400101595 400101596 400101597 400101598 400101600 400101601 400101602 400101603 400101604 400101605 400101606 400101607 400101608 400101609 400101611 400101612…
FDA’s list runs to 7,665 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 distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
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?
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 27, 2020.
- FDA classified it on Jun 17, 2020.
- FDA’s Enforcement Report published it on Jun 24, 2020.
- FDA terminated it on Jan 8, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Defibtech, LLC, of Guilford, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 7,665 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.