CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report

Photera 600, phototherapy device recalled by Daavlin Distributing

Daavlin Distributing is recalling Photera 600, phototherapy device, distributed nationwide in the US. The recall was initiated on 5 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 6-09033NB4CL, 6-09037NB4CL, 6-09031NB4CL, 6-09538NB4CL, 6-09038NB4CL, 6-09039NB4CL, 6-09040NB4CL, 6-09041NB4CL, 6-09035NB4CL, 6-09034NB4CL, 6-09030NB4CL, 6-09026NB4CL, 6-09023NB4CL, 6-09028NB4CL, 6-09025NB4CL, 6-09043NB4CL, 6-09029NB4CL, 6-09044NB4CL, 6-09022NB4CL, 6-09027NB4CL, 6-09036NB4CL, 6-09045NB4CL, 6-09024NB4CL, 6-07827NB4CL, 6-09539NB4CL, 6-09042NB4CL.

Quantity recalled26 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2743-2026
FDA event ID: 99331
Recalling firm: Daavlin Distributing, Bryan, OH
Classification: Class II
Status: Ongoing
Recall initiated: 5 Mar 2026
FDA classified: 15 Jul 2026
Reported: 22 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

5 Mar 2026	Recall initiated by company
15 Jul 2026	Classified by FDA	+132 days
22 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Photera 600, phototherapy device recalled?

Yes. Daavlin Distributing recalled Photera 600, phototherapy device on 5 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-2743-2026.

Why was it recalled?

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

Which lots are affected?

Serial Numbers: 6-09033NB4CL, 6-09037NB4CL, 6-09031NB4CL, 6-09538NB4CL, 6-09038NB4CL, 6-09039NB4CL, 6-09040NB4CL, 6-09041NB4CL, 6-09035NB4CL, 6-09034NB4CL, 6-09030NB4CL, 6-09026NB4CL, 6-09023NB4CL, 6-09028NB4CL, 6-09025NB4CL, 6-09043NB4CL, 6-09029NB4CL, 6-09044NB4CL, 6-09022NB4CL, 6-09027NB4CL, 6-09036NB4CL, 6-09045NB4CL, 6-09024NB4CL, 6-07827NB4CL, 6-09539NB4CL, 6-09042NB4CL.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Daavlin Distributing

All 6

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	Photera 400, phototherapy device recalled by Daavlin Distributing	Daavlin Distributing	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Photera 600 3-D, phototherapy device recalled by Daavlin Distributing	Daavlin Distributing	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	Phothera 200, Phototherapy Devices indicated recalled	Daavlin Distributing	Other	Nationwide
18 May 2022Device	CLASS II	4 Series CX phototherapy units equipped recalled by Daavlin Distributing	Daavlin Distributing	Device Malfunction	Nationwide
18 May 2022Device	CLASS II	1 Series CX phototherapy units equipped recalled by Daavlin Distributing	Daavlin Distributing	Device Malfunction	Nationwide

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