Photera 400 Phototherapy Device Recall

Source: FDA · United States

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 recalls two Photera 400 devices due to incorrect UV sensor calibration affecting output calculations.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 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 because the calibrated output on the Photera 400 was not calculating correctly. The UV Sensor GAIN being applied was incorrect, appearing as "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

Which Products Are Affected

The recall involves the Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders. Two units are affected, distributed nationwide in the United States. Serial numbers are 4-01440NB10CL and 4-01441NB10CL. Recall number Z-2742-2026.

What You Should Do

Consumers with affected units should refer to the recalling firm for guidance on the ongoing Class II recall.

Why This Matters

This Class II recall affects devices used for dermatologic disorders and was distributed across the United States.

Source

FDA recall number Z-2742-2026, event ID 99331.

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Daavlin Distributing Company recalls two Photera 400 devices due to incorrect UV sensor calibration affecting output calculations.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.