Reported Jul 9, 2014 · Terminated

DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of…

DeVilbiss Healthcare LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DeVilbiss Healthcare LLC · 100 Devilbiss Dr · Somerset, PA · 15501-2125

Is this the product you have?

  • 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.
Lot codes and dates
  • Model #
    • DV51D-HH
    • DV53D-HH
    • DV53D-HH-S
    • DV54D-HH
    • DV54D-HH-S
    • DV55D-HH
    • DV55D-HH-S
    • DV55D-S
    • DV57D-HH
    serial numbers

    1,809 of 1,809 codes

    • 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
Amount recalled
1809

Where it was sold

  • Nationwide

Why it was recalled

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".

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 2, 2014 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.