CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report
Photera 400, phototherapy device recalled by Daavlin Distributing
Daavlin Distributing is recalling Photera 400, 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
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-2742-2026
- 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 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Where it was distributed
US Nationwide distribution.
Questions about this recall
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: 4-01440NB10CL, 2 4-01441NB10CL.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99331This product is part of a recall event; the main page for the event is Photera 600 3-D, phototherapy device recalled by Daavlin Distributing.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Photera 600 3-D, phototherapy device recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide | |
| CLASS II | Photera 600, phototherapy device recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
More recalls from Daavlin Distributing
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Photera 600, phototherapy device recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
| Device | CLASS II | Photera 600 3-D, phototherapy device recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
| Device | CLASS II | Phothera 200, Phototherapy Devices indicated recalled | Daavlin Distributing | Other | Nationwide |
| Device | CLASS II | 4 Series CX phototherapy units equipped recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
| Device | CLASS II | 1 Series CX phototherapy units equipped recalled by Daavlin Distributing | Daavlin Distributing | Device Malfunction | Nationwide |
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