Diowave Laser System Recall Issued for Software Update
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Technological Medical Advancements LLC is recalling 16 Diowave Laser Systems because they operate beyond the FDA-cleared maximum average power output.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened Technological Medical Advancements LLC is conducting a voluntary recall of the Diowave Laser System because a software update is needed. The systems are operating at a maximum average power output of 70W, which exceeds the FDA-cleared limit of 60W for topical infrared heating intended to provide temporary relief of minor muscle and joint pain, spasms, and stiffness associated with minor arthritis, and to temporarily increase local blood circulation.
Which Products Are Affected The recall involves the Diowave Laser System, REF: Diowave 250W. A total of 16 units are affected. The UDI-DI is G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81 are included. Distribution was nationwide in the United States, including the states of TX, CA, MI, MD, PA, FL, MN, and DC. The recall number is Z-2162-2026.
What You Should Do Consumers should contact Technological Medical Advancements LLC regarding the software update.
Why This Matters This Class II recall addresses a device operating above its FDA-cleared power specifications.
Source FDA recall Z-2162-2026, Event ID 98507. https://www.fda.gov
Original source: FDA Official Notice ↗
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Similar body length
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Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.