Diowave Laser System — Class II medical device recall Z-2162-2026
Ongoing recall by Technological Medical Advancements LLC, reported 2026-05-20, distributed nationwide. Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor
| Recall number | Z-2162-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Technological Medical Advancements LLC, West Palm Beach, FL, United States |
| Recall initiated | 2026-01-09 |
| Classified | 2026-05-11 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 16 |
| Reason classes | software |
Product
Diowave Laser System, REF: Diowave 250W
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2162-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.