Accure Laser System Recall: Risk of Blistering from Misaligned Spot Tracking

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Recalling firmAccure Acne, Inc4699 Nautilus Ct S Ste 205, N/A · Boulder, CO 80301-5307

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Accure is recalling its Laser System model PFMS00004 because the spot tracking system might become misaligned, which could deliver too much laser energy to the skin and cause blistering. This recall affects specific units with listed serial numbers.

Why it’s dangerous

The laser system's spot tracking system may become misaligned, causing it to deliver higher-than-expected laser energy to the epidermal tissue. This can result in blistering of the skin, particularly during acne treatment sessions.

Who’s affected

Users of the Accure Laser System model PFMS00004 with specific serial numbers are affected. Individuals using the device for acne treatment are most at risk due to potential skin blistering.

How to tell if you have this one

Check for the model number PFMS00004 on the device. Affected units have specific serial numbers listed in the recall notice, including LAD0000-0001 through LAD2507-0723.

Brand
Accure
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number PFMS00004 on the device to confirm if it is affected.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled device?

The recalled device is model PFMS00004.

What could happen if the spot tracking system becomes misaligned?

Misalignment could cause the laser to deliver higher-than-expected energy to the skin, potentially leading to blistering.

How can I check if my device is affected?

Check for the model number PFMS00004 and verify your serial number against the list provided in the recall notice.

Take action

Contact Accure

We’ve drafted a message you can send Accure to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0778-2024 — Accure Accure

Hello,

I own a Accure that is covered by recall Z-0778-2024 from Accure.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0778-2024 (December 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0778-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Accure Acne, Inc recalls Accure Laser System, Model: PFMS00004

Lower-risk recall