Bryan, OH, United States
Daavlin Distributing Company recalls
3 recalls recorded since 2018, most recently on 5 March 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 March 2026
- Reason
- 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).
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2744-2026, Z-2742-2026, Z-2743-2026
- Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
- Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
- Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Ongoing Class II Medical devices
- Recall started
- 10 December 2025
- Reason
- Some of the Calibration/Output Certificates had the outputs reversed.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2295-2026
- 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 21
Ongoing Class II Medical devices
- Recall started
- 26 April 2022
- Reason
- Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1073-2022, Z-1074-2022
- 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, i
- 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.