Fresh Recalls

FDAClass II · Medical device · Recall Z-2295-2026 · Recalled June 10, 2026

Phothera 200 recall — Daavlin Distributing Company

Agency report date: June 10, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Phothera 200
Company / brand
Daavlin Distributing Company
Lot / serial / date codes
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
US Nationwide distribution.
Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Some of the Calibration/Output Certificates had the outputs reversed.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Phothera 200 recall status

3. Open the official notice or contact

Official recall ID
Z-2295-2026
Brand
All Daavlin Distributing Company recalls
Classification
Class II
Units affected
368 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Bryan, OH, United States
Firm address
205 W Bement St, 43506-1264

Identifying details (verbatim from the notice)

Product codes / lots
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
US Nationwide distribution.
Firm notified the public via
Letter
FDA event ID
98817
Recall initiated
December 10, 2025
FDA classified
June 2, 2026
FDA report date
June 10, 2026

Other medical device recalls from around the same time

Verify with the official sources:

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 8, 2026 at 6:00 PM UTC.

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