Reported Jan 31, 2024 · Ongoing

Accure Laser System, Model: PFMS00004

Accure Acne, Inc.

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: Accure Acne, Inc · 4699 Nautilus Ct S Ste 205 · Boulder, CO · 80301-5307

Is this the product you have?

  • Accure Laser System
  • ModelPFMS00004
Lot codes and dates
  • UDI-DI08059173392230
  • Serial Numbers
    • LAD0000-0004
    • LAD0000-0014
    • PROT01-0720
    • LAD0000-0012
    • LAD0000-0005
    • LAD2216-0623
    • LAD2356-0723
    • LAD0000-0003
    • PROTO07-1120
    • LAD2076-0623
    • LAD0000-0011
    • LAD0000-0008
    • LAD0000-0010
    • LAD2357-0723
    • LAD2075-0623
    • LAD2232-0723
    • LAD0000-0013
    • LAD0000-0009
    • LAD0000-0006
    • LAD0000-0001
    • PROT06-1120
    • LAD2507-0723
Amount recalled
22

Where it was sold

Why it was recalled

Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.

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

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.