FDAClass II · Medical device · Recall Z-2162-2026 · Recalled May 20, 2026

Diowave Laser System recall — Technological Medical Advancements LLC

Agency report date: May 20, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Diowave Laser System
Company / brand: Technological Medical Advancements
Lot / serial / date codes: UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Distribution: US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.

Agency product description and boundaries

Diowave Laser System, REF: Diowave 250W

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Diowave Laser System recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2162-2026
Brand: All Technological Medical Advancements recalls
Classification: Class II
Units affected: 16
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Diowave Laser System recall status

Companies & origin

Recalling firm location: West Palm Beach, FL, United States
Firm address: 1601 Belvedere Rd Ste E-180, 33406-1541

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Distribution: US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Firm notified the public via: Letter
FDA event ID: 98507
Recall initiated: January 9, 2026
FDA classified: May 11, 2026
FDA report date: May 20, 2026

Other medical device recalls from around the same time

Automated Impella Controller (AIC) recall — Abiomed, Inc.FDA · June 3, 2026
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers recall — Bolton Medical Inc.FDA · June 3, 2026
NextStep Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
Cannon II Plus Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 18, 2026 at 6:00 PM UTC.

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