Smaxel Fractional CO2 Laser recalled for missing safety label and instructions
IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The device is classified as FDA Class II, indicating potential for adverse health consequences. The hazard—missing Certification label and inadequate operational instructions—creates a risk of improper device use and potential patient harm. No illnesses or injuries have been reported.
Plain-English summary
The Smaxel Fractional CO2 Laser, a Class IV medical laser system manufactured by IDS LTD, is being recalled. A total of 23 units were distributed worldwide, including throughout the United States.
The recalled laser systems do not include the required Certification label and lack adequate instructions for safe operation. These missing safety components prevent proper training and safe use of the medical device.
Users of the recalled laser systems should immediately discontinue use and contact the manufacturer for further instructions. Healthcare facilities and practitioners should verify that their equipment is not part of this recall using FDA recall number Z-0804-2025.
The recalled product
- Product
- Smaxel Fractional CO2 Laser, a Class IV medical laser system.
- Manufacturer
- IDS LTD
- Category
- Medical Device
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- unknown
Distribution
Distributed nationwide across the United States.
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