Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's 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) and recall number Z-2295-2026, then follow Daavlin Distributing Company's recall.

Recall Record: Class II Recall: Phothera 200, Phototherapy Devices indicated for use to… by Daavlin Distributing Company

Daavlin Distributing Company recalled 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 on 2026-06-10. FDA classified this action as a Class II recall (recall number Z-2295-2026). Reason for recall: Some of the Calibration/Output Certificates had the outputs reversed.. Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Daavlin Distributing Company
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product 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
Classification	Class II
Recall number	Z-2295-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Some of the Calibration/Output Certificates had the outputs reversed.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Daavlin Distributing Company and the affected product is described in FDA's record as: 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. FDA's stated reason for the recall is: Some of the Calibration/Output Certificates had the outputs reversed.. The recall is tracked under FDA recall number Z-2295-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 -- and the recall number Z-2295-2026. If it matches, stop using or distributing it and contact Daavlin Distributing Company or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Daavlin Distributing Company’s FDA history

Argus HQ has recorded 1 total FDA action tied to Daavlin Distributing Company: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
What was recalled and why?: Daavlin Distributing Company recalled 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. FDA's record states the reason for recall as: Some of the Calibration/Output Certificates had the outputs reversed.. The recall is logged under FDA recall number Z-2295-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's 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) and recall number Z-2295-2026, then follow Daavlin Distributing Company's recall.

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Full FDA history for Daavlin Distributing Company

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: Phothera 200, Phototherapy Devices indicated for use to… by Daavlin Distributing Company. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-daavlin-distributing-company-z-2295-2026

MLA

"Recall Record: Class II Recall: Phothera 200, Phototherapy Devices indicated for use to… by Daavlin Distributing Company." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-daavlin-distributing-company-z-2295-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: Phothera 200, Phototherapy Devices indicated for use to… by Daavlin Distributing Company." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-daavlin-distributing-company-z-2295-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_daavlin_distributing_company_z_2295_2026_2026,
  title = {Recall Record: Class II Recall: Phothera 200, Phototherapy Devices indicated for use to… by Daavlin Distributing Company},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-daavlin-distributing-company-z-2295-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗