Shark CryoGlow FW312Recalls & reported problems

SharkNinja Operating LLC · The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles. The Model Number is FW312. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00622356642804), received between Mar 4, 2026 and Mar 19, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Insufficient Device Problem Information2

Patient problems

Dry Skin1
Erythema1
Eye Irritation1
Hypersensitivity/Allergic reaction1
Skin Burning Sensation1
Skin Discoloration1
Skin Inflammation/ Irritation1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMar 19, 2026Insufficient Device Problem Information
THE CUSTOMER REPORTED WITH REDNESS AND DRY SKIN ARORUND THE NOSE AND MOUTH. GP ADVISED TO STOP USING THE MASK AND PRESCRIBED VARIOUS CREAMS PRODUCTS FOR THE SKIN DRYNESS.
Patient problems: Dry Skin; Erythema; Skin Discoloration
MAUDE report 24643460 ↗
InjuryMar 4, 2026Insufficient Device Problem Information
THE CUSTOMER REPORTED RED UNDER HER EYES AND SAW A MEDICAL PROFESSIONAL THAT ADVISED NOT TO USE THE MASK AGAIN AND PRESCRIBED MEDICATION.
Patient problems: Eye Irritation; Hypersensitivity/Allergic reaction; Skin Burning Sensation; Skin Inflammation/ Irritation
MAUDE report 24507935 ↗

Device details

UDI-DI	`00622356642804`
Brand	Shark CryoGlow
Model	FW312
Catalog no.	FW300
Company	SharkNinja Operating LLC
Product code	OHS · Light Based Over The Counter Wrinkle Reduction
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2026

Device type (GMDN): Red/blue light phototherapy unit

A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Other Light Based Over The Counter Wrinkle Reduction devices

NIRA PRO 151-000
Nira Innovations Incorporated · Light Based Over The Counter Wrinkle Reduction
1 report
NIRA Pro+ 174-000
Nira Innovations Incorporated · Light Based Over The Counter Wrinkle Reduction
1 report

All Light Based Over The Counter Wrinkle Reduction devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page