Quick Facts at a Glance
- Recall Date
- December 10, 2025
- Hazard Level
- HIGH
- Brand
- Daavlin Distributing
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Daavlin Distributing
- Model numbers
- 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
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 10, 2025
Reported by FDA DEVICE
June 10, 2026
RecallRadar source check
June 16, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Some of the Calibration/Output Certificates had the outputs reversed.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Daavlin Distributing Company or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. Reason: Some of the Calibration/Output Certificates had the outputs reversed.. Classification: Class II. Quantity: 368 units. Distribution: US Nationwide distribution.
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Safety Guide
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