The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1495-2018·Announced 2018-05-09

Beijing Syntech Laser UL Station surgical lasers recalled for missing certification label

Beijing Syntech Laser Co., Ltd is recalling 199 UL Station surgical lasers because the required laser safety 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 and involves a labeling error (missing certification label) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Beijing Syntech Laser Co., Ltd is recalling 199 units of the UL Station surgical laser. The recall was initiated because the product did not have the required certification label affixed to it. This label is necessary to state that the device complies with 21 CFR 1040.10 and 1040.11, except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.

The affected products were distributed in the United States. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any illnesses or injuries associated with this noncompliance.

Consumers and healthcare facilities with these devices should contact the recalling firm for instructions on how to proceed. The primary issue is a documentation and labeling defect regarding laser safety compliance.

The recalled product

Product
Beijing Syntech Laser UL Station surgical lasers
Manufacturer
Beijing Syntech Laser Co., Ltd
Category
Medical Device — Surgical Laser
Hazard
Affected units
199

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 Station

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