CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Diowave Laser System recalled by Technological Medical
Technological Medical Advancements is recalling Diowave Laser System, distributed nationwide in the US. The recall was initiated on 9 Jan 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-2162-2026
- FDA event ID
- 98507
- Recalling firm
- Technological Medical Advancements, West Palm Beach, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2026
- FDA classified
- 11 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2026 | Recall initiated by company | |
| 11 May 2026 | Classified by FDA | +122 days |
| 20 May 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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
Diowave Laser System, REF: Diowave 250W
Where it was distributed
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Nationwide CaliforniaDistrict of ColumbiaFloridaMarylandMichiganMinnesotaPennsylvaniaTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Where was it sold?
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
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.
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