FDA Device recall Z-2162-2026
Diowave Laser System, REF: Diowave 250W
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Diowave Laser System, REF: Diowave 250W by Technological Medical Advancements, citing software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2162-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-09 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Technological Medical Advancements |
| Distribution | US |
Product
Diowave Laser System, REF: Diowave 250W
Reason
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Identifiers
| code_info | UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2162-2026%22
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