DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of…
Medical device recall Z-1949-2014. Published in FDA’s Enforcement Report on Jul 9, 2014.
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 9, 2014. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1809 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 III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as “RUN-TEST”.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
1809, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH serial numbers KD012316 JD034349 JD034384 JD034389 HD070335 HD070339 HD070352 HD070357 HD070377 HD070379 HD070395 HD071128 HD071138 HD071154…
Every code shown here, 1,999 characters
Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH serial numbers KD012316 JD034349 JD034384 JD034389 HD070335 HD070339 HD070352 HD070357 HD070377 HD070379 HD070395 HD071128 HD071138 HD071154 HD071278 HD070474 HD070736 JD034560 JD034566 HD070219 HD070162 HD070172 HD070174 HD070178 HD070182 HD070827 HD070961 HD071003 HD071004 HD071007 HD071009 HD071020 HD071021 HD071022 HD071030 HD071032 HD071033 HD071040 HD071043 HD071045 HD071048 HD071057 HD071058 HD071059 HD071062 HD071063 HD071064 HD071065 HD071069 HD071072 JD034492 JD034497 JD034504 JD034506 JD034507 JD034540 JD034543 JD034553 JD034554 JD034555 HD071068 JD034316 JD034317 JD034327 JD034328 JD034329 JD034330 JD034331 JD034332 JD034333 JD034334 HD070167 HD070171 HD070177 HD070190 HD070191 HD070198 HD070206 HD070212 HD070223 HD070225 HD070248 HD070249 HD070279 HD069902 HD069903 HD069906 HD069907 HD070533 HD070534 HD070545 HD070548 HD070563 HD070598 HD070605 JD034598 JD034599 JD034601 JD034603 JD034604 HD070724 HD070749 HD070756 HD070758 HD070760 HD070763 HD070767 HD070779 HD070781 HD070783 HD070787 HD070797 JD034569 JD034571 JD034576 JD034578 JD034586 JD034588 JD034591 JD034592 JD034597 HD069969 HD070722 HD070728 HD070733 HD070761 HD070784 JD034519 JD034602 JD034609 JD034613 JD034614 kd014347 HD069922 HD069905 HD069916 HD069917 JD034156 JD034158 JD034159 JD034163 JD034165 JD034185 JD034186 KD014349 KD014350 JD034209 JD034212 JD034231 JD034235 JD034239 JD034242 JD034584 JD034587 JD034589 JD034568 JD034581 JD034582 HD070283 HD070301 JD034161 JD034171 HD069927 HD069929 HD069930 HD069932 HD069949 HD069951 JD034211 JD034226 KD014329 HD070482 HD070483 HD070500 HD070556 HD070719 HD070720 HD070791 HD070800 HD070828 ID039134 ID039150 ID039167 KD014117 JD034402 KD014229 JD034154 JD034155 JD034160 JD034183 JD034188 JD034189 JD034190 JD034192 JD034193 JD034197 JD034221 JD034224 JD034229 JD034230 JD034232 JD034233 JD034162 JD034217 JD034236 JD034237 JD034240 JD034241 JD034244 JD034391…
FDA’s list runs to 16,389 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 - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.
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 May 13, 2014.
- FDA classified it on Jul 1, 2014.
- FDA’s Enforcement Report published it on Jul 9, 2014.
- FDA terminated it on Dec 2, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- DeVilbiss Healthcare LLC, of Somerset, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
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 16,389 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
-
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.