Reported May 10, 2023 · Ongoing

DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

DermLite LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DermLite LLC · 31521 Rancho Viejo Rd Ste 104 · San Juan Capistrano, CA · 92675-1868

Is this the product you have?

  • DERMLITE DL4W
  • REFDL4W, Rx Only MD, CE
Lot codes and dates
  • Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504)
  • UDI-DI(01) 0 8559970
Amount recalled
32 units

Where it was sold

Why it was recalled

Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

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