Phothera 200 Phototherapy Devices Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Daavlin Distributing Company is recalling 368 Phothera 200 phototherapy devices nationwide because some calibration certificates had outputs reversed.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Daavlin Distributing Company initiated a voluntary recall of Phothera 200 phototherapy devices after determining that some Calibration/Output Certificates had the outputs reversed.
Which Products Are Affected
The recall covers Phothera 200 Phototherapy Devices (Model Numbers 210NDT4 and 210NCL4) indicated for treatment of diagnosed skin disorders such as Psoriasis, Vitiligo, and Atopic Dermatitis under physician direction. A total of 368 units distributed nationwide in the United States are affected. Affected units are identified by the listed serial numbers in recall Z-2295-2026.
What You Should Do
Consumers should follow instructions provided by the recalling firm regarding the affected devices.
Why This Matters
The Class II recall involves devices distributed across the United States that may have incorrect calibration documentation.
Source
FDA Recall Z-2295-2026 - Daavlin Distributing Company, Bryan, OH
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (976 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.