SkinPen Precision Microneedling System REF100/REF101Recalls & reported problems

Bellus Medical, LLC · SkinPen Assembly (includes SkinPen Precision hand-piece, charging base, and AC Adapter). · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00863221000330), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Off-Label Use1

Patient problems

Angioedema1
Hypersensitivity/Allergic reaction1
Itching Sensation1
Rash1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryFeb 6, 2025Off-Label Use; Off-Label Use
PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT MICRONEEDLING AND THE USE OF BIOSOMES FOLLOWING THE MICORNEEDLING TREATMENT. HEALTHCARE PROVIDER REPORTED THAT PATIENT HAD A SENSITIVITY TO AUGMENTIN, SINTOMYCIN, DALCIN AND SINOPHED. ONE HOUR FOLLOWING THE MICRONEEDLING AND BIOSOME TREATMENT, THE PATIENT EXPERIENCED ITCHING ALL OVER THE BODY AND AN URTICARIAL RASH. THE PATIENT WAS EXAMINED IN THE EMERGENCY ROOM AND WAS TREATED WITH STERIODS AND AN IV OF TELEFAST. CLINICIAN REPORTED PATIENT'S CONDITION RESOLVED.
Patient problems: Angioedema; Hypersensitivity/Allergic reaction; Itching Sensation; Rash
MAUDE report 21322885 ↗

Device details

UDI-DI	`00863221000330`
Brand	SkinPen Precision Microneedling System
Model	REF100/REF101
Catalog no.	F5SP004
Company	Bellus Medical, LLC
Product code	QAI · Powered Microneedle Device
Class	Class 2
FDA submission	DEN160029
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 3, 2024

Device type (GMDN): Cosmetic micro-needling electronic handpiece, professional

A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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