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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98817

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 10, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Daavlin Distributing Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

Z-2295-2026
Recall number
Z-2295-2026
Initiated
December 10, 2025
Classification
Class II
Status
Ongoing
Quantity
368 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the Calibration/Output Certificates had the outputs reversed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some of the Calibration/Output Certificates had the outputs reversed.

Code information

Serial Numbers: 2-03409NB4DT 2-03560NB4DT 2-03798NB4DT 2-03472NB4DT 2-03315NB4DT 2-03726NB4DT 2-03396NB4DT 2-03320NB4DT 2-03447NB4DT 2-03564NB4DT 2-03516NB4DT 2-03467NB4DT 2-03292NB4DT 2-03371NB4DT 2-03433NB4DT 2-03446NB4DT 2-03343NB4DT 2-03400NB4DT 2-03342NB4DT 2-03547NB4DT 2-03449NB4DT 2-03685NB4DT 2-03574NB4DT 2-03392NB4DT 2-03345NB4DT 2-03431NB4DT 2-03608NB4DT 2-03530NB4DT 2-03501NB4DT 2-03362NB4DT 2-03603NB4DT 2-03713NB4DT 2-03508NB4DT 2-03341NB4DT 2-03418NB4DT 2-03721NB4DT 2-03662NB4DT 2-03679NB4DT 2-03591NB4DT 2-03319NB4DT 2-03411NB4DT 2-03505NB4DT 2-03335NB4DT 2-03585NB4DT 2-03556NB4DT 2-03355NB4DT 2-03664NB4DT 2-03515NB4DT 2-03424NB4DT 2-03470NB4DT 2-03386NB4DT 2-03455NB4DT 2-03401NB4DT 2-03391NB4DT 2-03578NB4DT 2-03388NB4DT 2-03632NB4DT 2-03615NB4DT 2-03434NB4DT 2-03454NB4DT 2-03387NB4DT 2-03390NB4DT 2-03569NB4DT 2-03541NB4DT 2-03509NB4DT 2-03789NB4DT 2-03804NB4DT 2-03439NB4DT 2-03367NB4DT 2-03442NB4DT 2-03750NB4DT 2-03349NB4DT 2-03510NB4DT 2-03538NB4DT 2-03559NB4DT 2-03539NB4DT 2-03491NB4DT 2-03502NB4DT 2-03629NB4DT 2-03383NB4DT 2-03496NB4DT 2-03619NB4DT 2-03511NB4DT 2-03670NB4DT 2-03565NB4DT 2-03581NB4DT 2-03479NB4DT 2-03348NB4DT 2-03534NB4DT 2-03484NB4DT 2-03802NB4DT 2-03504NB4DT 2-03457NB4DT 2-03417NB4DT 2-03482NB4DT 2-03318NB4DT 2-03503NB4DT 2-03518NB4DT 2-03350NB4DT 2-03686NB4DT 2-03317NB4DT 2-03687NB4DT 2-03507NB4DT 2-03663NB4DT 2-03658NB4DT 2-03330NB4DT 2-03489NB4DT 2-03451NB4DT 2-03486NB4DT 2-03465NB4DT 2-03346NB4DT 2-03598NB4DT 2-03377NB4DT 2-03414NB4DT 2-03422NB4DT 2-03531NB4DT 2-03329NB4DT 2-03579NB4DT 2-03817NB4DT 2-03613NB4DT 2-03322NB4DT 2-03570NB4DT 2-03397NB4DT 2-03326NB4DT 2-03347NB4DT 2-03469NB4DT 2-03483NB4DT 2-03359NB4DT 2-03344NB4DT 2-03436NB4DT 2-03711NB4DT 2-03437NB4DT 2-03459NB4DT 2-03384NB4DT 2-03389NB4DT 2-03592NB4DT 2-03432NB4DT 2-03823NB4DT 2-03616NB4DT 2-03498NB4DT 2-03512NB4DT 2-03809NB4DT 2-03647NB4DT 2-03606NB4DT 2-03722NB4DT 2-03818NB4DT 2-03589NB4DT 2-03356NB4DT 2-03583NB4DT 2-03799NB4DT 2-03487NB4DT 2-03398NB4DT 2-03775NB4DT 2-03427NB4DT 2-03533NB4DT 2-03676NB4DT 2-03468NB4DT 2-03684NB4DT 2-03413NB4DT 2-03716NB4DT 2-03374NB4DT 2-03430NB4DT 2-03473NB4DT 2-03575NB4DT 2-03339NB4DT 2-03666NB4DT 2-03323NB4DT 2-03471NB4DT 2-03334NB4DT 2-03310NB4DT 2-03631NB4DT 2-03405NB4DT 2-03720NB4DT 2-03372NB4DT 2-03463NB4DT 2-03353NB4DT 2-03563NB4DT 2-03419NB4DT 2-03725NB4DT 2-03621NB4DT 2-03336NB4DT 2-03312NB4DT 2-03806NB4DT 2-03572NB4DT 2-03597NB4DT 2-03370NB4DT 2-03435NB4DT 2-03354NB4DT 2-03555NB4DT 2-03440NB4DT 2-03376NB4DT 2-03610NB4DT 2-03653NB4DT 2-03749NB4DT 2-03380NB4DT 2-03558NB4DT 2-03462NB4DT 2-03313NB4DT 2-03517NB4DT 2-03790NB4DT 2-03513NB4DT 2-03602NB4DT 2-03683NB4DT 2-03561NB4DT 2-03514NB4DT 2-03604NB4DT 2-03445NB4DT 2-03423NB4DT 2-03338NB4DT 2-03375NB4DT 2-03361NB4DT 2-03543NB4DT 2-03492NB4DT 2-03801NB4DT 2-03497NB4DT 2-03601NB4DT 2-03824NB4DT 2-03477NB4DT 2-03545NB4DT 2-03813NB4DT 2-03557NB4DT 2-03426NB4DT 2-03428NB4DT 2-03394NB4DT 2-03645NB4DT 2-03842NB4DT 2-03528NB4DT 2-03321NB4DT 2-03478NB4DT 2-03438NB4DT 2-03369NB4DT 2-03661NB4DT 2-03682NB4DT 2-03412NB4DT 2-03351NB4DT 2-03673NB4DT 2-03453NB4DT 2-03605NB4DT 2-03461NB4DT 2-03495NB4DT 2-03582NB4DT 2-03540NB4DT 2-03594NB4DT 2-03612NB4DT 2-03810NB4DT 2-03364NB4DT 2-03609NB4DT 2-03672NB4DT 2-03529NB4DT 2-03379NB4DT 2-03554NB4DT 2-03490NB4DT 2-03407NB4DT 2-03586NB4DT 2-03600NB4DT 2-03618NB4DT 2-03421NB4DT 2-03659NB4DT 2-03671NB4DT 2-03448NB4DT 2-03607NB4DT 2-03402NB4DT 2-03485NB4DT 2-03480NB4DT 2-03420NB4DT 2-03328NB4DT 2-03408NB4DT 2-03481NB4DT 2-03625NB4DT 2-03331NB4DT 2-03614NB4DT 2-03646NB4DT 2-03668NB4DT 2-03800NB4DT 2-03499NB4DT 2-03753NB4DT 2-03520NB4DT 2-03464NB4DT 2-03316NB4DT 2-03580NB4DT 2-03675NB4DT 2-03665NB4DT 2-03546NB4DT 2-03590NB4DT 2-03544NB4DT 2-03415NB4DT 2-03719NB4DT 2-03456NB4DT 2-03532NB4DT 2-03385NB4DT 2-03452NB4DT 2-03593NB4DT 2-03366NB4DT 2-03759NB4DT 2-03506NB4DT 2-03425NB4DT 2-03660NB4DT 2-03360NB4DT 2-03519NB4DT 2-03688NB4DT 2-03537NB4DT 2-03429NB4DT 2-03406NB4DT 2-03340NB4DT 2-03311NB4DT 2-03562NB4DT 2-03474NB4DT 2-03655NB4DT 2-03466NB4DT 2-03595NB4DT 2-03476NB4DT 2-03403NB4DT 2-03752NB4DT 2-03332NB4DT 2-03314NB4DT 2-03309NB4DT 2-03678NB4DT 2-03410NB4DT 2-03460NB4DT 2-03717NB4DT 2-03521NB4DT 2-03674NB4DT 2-03363NB4DT 2-03667NB4DT 2-03475NB4DT 2-03724NB4DT 2-03493NB4DT 2-03617NB4DT 2-03680NB4DT 2-03494NB4DT 2-03450NB4DT 2-03754NB4DT 2-03378NB4DT 2-03712NB4DT 2-03840NB4DT 2-03441NB4DT 2-03416NB4DT 2-03393NB4DT 2-03577NB4DT 2-03751NB4DT 2-03681NB4DT 2-03368NB4DT 2-03333NB4DT 2-03640NB4DT 2-03373NB4DT 2-03358NB4DT 2-03500NB4DT 2-03596NB4DT 2-03811NB4DT 2-03308NB4DT 2-03669NB4DT 2-03337NB4DT 2-03381NB4DT 2-03352NB4DT 2-03488NB4DT 2-03382NB4DT 2-03443NB4DT 2-03357NB4DT 2-03444NB4DT 2-03542NB4DT 2-03599NB4DT 2-03404NB4DT 2-03395NB4DT 2-03365NB4DT 2-03399NB4DT 2-03576NB4DT 2-03458NB4DT 2-03611NB4DT

Distribution pattern

US Nationwide distribution.