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RecallWatchMedical Device Safety
Class IIOngoingZ-2295-2026

Daavlin Distributing Company recalls Phothera 200

Daavlin Distributing CompanyBryan, OH, United StatesReported Jun 10, 2026 · 1 month ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 and210NCL4
    368 affected lots
    2-03409NB4DT2-03560NB4DT2-03798NB4DT2-03472NB4DT2-03315NB4DT2-03726NB4DT2-03396NB4DT2-03320NB4DT
    +360 more2-03447NB4DT2-03564NB4DT2-03516NB4DT2-03467NB4DT2-03292NB4DT2-03371NB4DT2-03433NB4DT2-03446NB4DT2-03343NB4DT2-03400NB4DT2-03342NB4DT2-03547NB4DT2-03449NB4DT2-03685NB4DT2-03574NB4DT2-03392NB4DT2-03345NB4DT2-03431NB4DT2-03608NB4DT2-03530NB4DT2-03501NB4DT2-03362NB4DT2-03603NB4DT2-03713NB4DT2-03508NB4DT2-03341NB4DT2-03418NB4DT2-03721NB4DT2-03662NB4DT2-03679NB4DT2-03591NB4DT2-03319NB4DT2-03411NB4DT2-03505NB4DT2-03335NB4DT2-03585NB4DT2-03556NB4DT2-03355NB4DT2-03664NB4DT2-03515NB4DT2-03424NB4DT2-03470NB4DT2-03386NB4DT2-03455NB4DT2-03401NB4DT2-03391NB4DT2-03578NB4DT2-03388NB4DT2-03632NB4DT2-03615NB4DT2-03434NB4DT2-03454NB4DT2-03387NB4DT2-03390NB4DT2-03569NB4DT2-03541NB4DT2-03509NB4DT2-03789NB4DT2-03804NB4DT2-03439NB4DT2-03367NB4DT2-03442NB4DT2-03750NB4DT2-03349NB4DT2-03510NB4DT2-03538NB4DT2-03559NB4DT2-03539NB4DT2-03491NB4DT2-03502NB4DT2-03629NB4DT2-03383NB4DT2-03496NB4DT2-03619NB4DT2-03511NB4DT2-03670NB4DT2-03565NB4DT2-03581NB4DT2-03479NB4DT2-03348NB4DT2-03534NB4DT2-03484NB4DT2-03802NB4DT2-03504NB4DT2-03457NB4DT2-03417NB4DT2-03482NB4DT2-03318NB4DT2-03503NB4DT2-03518NB4DT2-03350NB4DT2-03686NB4DT2-03317NB4DT2-03687NB4DT2-03507NB4DT2-03663NB4DT2-03658NB4DT2-03330NB4DT2-03489NB4DT2-03451NB4DT2-03486NB4DT2-03465NB4DT2-03346NB4DT2-03598NB4DT2-03377NB4DT2-03414NB4DT2-03422NB4DT2-03531NB4DT2-03329NB4DT2-03579NB4DT2-03817NB4DT2-03613NB4DT2-03322NB4DT2-03570NB4DT2-03397NB4DT2-03326NB4DT2-03347NB4DT2-03469NB4DT2-03483NB4DT2-03359NB4DT2-03344NB4DT2-03436NB4DT2-03711NB4DT2-03437NB4DT2-03459NB4DT2-03384NB4DT2-03389NB4DT2-03592NB4DT2-03432NB4DT2-03823NB4DT2-03616NB4DT2-03498NB4DT2-03512NB4DT2-03809NB4DT2-03647NB4DT2-03606NB4DT2-03722NB4DT2-03818NB4DT2-03589NB4DT2-03356NB4DT2-03583NB4DT2-03799NB4DT2-03487NB4DT2-03398NB4DT2-03775NB4DT2-03427NB4DT2-03533NB4DT2-03676NB4DT2-03468NB4DT2-03684NB4DT2-03413NB4DT2-03716NB4DT2-03374NB4DT2-03430NB4DT2-03473NB4DT2-03575NB4DT2-03339NB4DT2-03666NB4DT2-03323NB4DT2-03471NB4DT2-03334NB4DT2-03310NB4DT2-03631NB4DT2-03405NB4DT2-03720NB4DT2-03372NB4DT2-03463NB4DT2-03353NB4DT2-03563NB4DT2-03419NB4DT2-03725NB4DT2-03621NB4DT2-03336NB4DT2-03312NB4DT2-03806NB4DT2-03572NB4DT2-03597NB4DT2-03370NB4DT2-03435NB4DT2-03354NB4DT2-03555NB4DT2-03440NB4DT2-03376NB4DT2-03610NB4DT2-03653NB4DT2-03749NB4DT2-03380NB4DT2-03558NB4DT2-03462NB4DT2-03313NB4DT2-03517NB4DT2-03790NB4DT2-03513NB4DT2-03602NB4DT2-03683NB4DT2-03561NB4DT2-03514NB4DT2-03604NB4DT2-03445NB4DT2-03423NB4DT2-03338NB4DT2-03375NB4DT2-03361NB4DT2-03543NB4DT2-03492NB4DT2-03801NB4DT2-03497NB4DT2-03601NB4DT2-03824NB4DT2-03477NB4DT2-03545NB4DT2-03813NB4DT2-03557NB4DT2-03426NB4DT2-03428NB4DT2-03394NB4DT2-03645NB4DT2-03842NB4DT2-03528NB4DT2-03321NB4DT2-03478NB4DT2-03438NB4DT2-03369NB4DT2-03661NB4DT2-03682NB4DT2-03412NB4DT2-03351NB4DT2-03673NB4DT2-03453NB4DT2-03605NB4DT2-03461NB4DT2-03495NB4DT2-03582NB4DT2-03540NB4DT2-03594NB4DT2-03612NB4DT2-03810NB4DT2-03364NB4DT2-03609NB4DT2-03672NB4DT2-03529NB4DT2-03379NB4DT2-03554NB4DT2-03490NB4DT2-03407NB4DT2-03586NB4DT2-03600NB4DT2-03618NB4DT2-03421NB4DT2-03659NB4DT2-03671NB4DT2-03448NB4DT2-03607NB4DT2-03402NB4DT2-03485NB4DT2-03480NB4DT2-03420NB4DT2-03328NB4DT2-03408NB4DT2-03481NB4DT2-03625NB4DT2-03331NB4DT2-03614NB4DT2-03646NB4DT2-03668NB4DT2-03800NB4DT2-03499NB4DT2-03753NB4DT2-03520NB4DT2-03464NB4DT2-03316NB4DT2-03580NB4DT2-03675NB4DT2-03665NB4DT2-03546NB4DT2-03590NB4DT2-03544NB4DT2-03415NB4DT2-03719NB4DT2-03456NB4DT2-03532NB4DT2-03385NB4DT2-03452NB4DT2-03593NB4DT2-03366NB4DT2-03759NB4DT2-03506NB4DT2-03425NB4DT2-03660NB4DT2-03360NB4DT2-03519NB4DT2-03688NB4DT2-03537NB4DT2-03429NB4DT2-03406NB4DT2-03340NB4DT2-03311NB4DT2-03562NB4DT2-03474NB4DT2-03655NB4DT2-03466NB4DT2-03595NB4DT2-03476NB4DT2-03403NB4DT2-03752NB4DT2-03332NB4DT2-03314NB4DT2-03309NB4DT2-03678NB4DT2-03410NB4DT2-03460NB4DT2-03717NB4DT2-03521NB4DT2-03674NB4DT2-03363NB4DT2-03667NB4DT2-03475NB4DT2-03724NB4DT2-03493NB4DT2-03617NB4DT2-03680NB4DT2-03494NB4DT2-03450NB4DT2-03754NB4DT2-03378NB4DT2-03712NB4DT2-03840NB4DT2-03441NB4DT2-03416NB4DT2-03393NB4DT2-03577NB4DT2-03751NB4DT2-03681NB4DT2-03368NB4DT2-03333NB4DT2-03640NB4DT2-03373NB4DT2-03358NB4DT2-03500NB4DT2-03596NB4DT2-03811NB4DT2-03308NB4DT2-03669NB4DT2-03337NB4DT2-03381NB4DT2-03352NB4DT2-03488NB4DT2-03382NB4DT2-03443NB4DT2-03357NB4DT2-03444NB4DT2-03542NB4DT2-03599NB4DT2-03404NB4DT2-03395NB4DT2-03365NB4DT2-03399NB4DT2-03576NB4DT2-03458NB4DT2-03611NB4DT

What the firm is doing

An URGENT: MEDICAL DEVICE ADVISORY NOTICE dated 12/11/25 was sent to customers. Dual calibration allows you to treat at the surface (0 ) of the device or at 9 inches (9 ) away. It has come to our attention that some of the Calibration/Output Certificates had the outputs reversed. Actions to be taken by the Customer/User: Talk to your physician regarding treatment plans with the new information listed below. If you have any questions or concerns, please do not hesitate to contact our office at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Thank you for your cooperation.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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