The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1491-2018·Announced 2018-05-09

Beijing Syntech Laser UL C02 Laser surgical lasers recalled for missing label

Beijing Syntech Laser Co., Ltd is recalling 92 UL C02 Laser surgical lasers because the required certification label was not affixed to the product.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling noncompliance (missing certification label) rather than a defect causing injury or illness, aligning with the 'Moderate' criteria for minor labeling errors.

Plain-English summary

Beijing Syntech Laser Co., Ltd is recalling 92 units of the UL C02 Laser surgical laser. The recall was initiated because the product did not have the required certification label affixed to it.

The missing label was required to state that the product complies with 21 CFR 1040.10 and 1040.11, except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007. The agency classified this recall as Class II.

The source text does not specify the distribution locations or provide instructions for consumers on how to return the product. No injuries or illnesses were reported in the source text.

The recalled product

Product
Beijing Syntech Laser UL C02 Laser surgical lasers
Manufacturer
Beijing Syntech Laser Co., Ltd
Category
Medical Device — Surgical Laser
Hazard
Affected units
92

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)

  • Model UL C02 Laser

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 8 recalled by Beijing Syntech Laser Co., Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Beijing Syntech Laser Co., Ltd

See all →

Same hazard · mis labeling

See all →

Similar recalls