Beijing Syntech Laser APOLLO JV+ Medical Platform Recalled for Missing Label
Beijing Syntech Laser is recalling six APOLLO JV+ Medical Platform surgical lasers because the required certification label was not affixed to the products.
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 a moderate severity score.
Plain-English summary
Beijing Syntech Laser Co., Ltd is recalling six units of the APOLLO JV+ Medical Platform surgical lasers. The recall was initiated because the products did not have the required certification label affixed to them.
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 affected units were distributed in the US. Consumers and healthcare providers who possess these specific surgical lasers should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
- Manufacturer
- Beijing Syntech Laser Co., Ltd
- Category
- Medical Device — Surgical Lasers
- Hazard
- Affected units
- 6
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 APOLLO 1V+Medical Platform
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 →- ModerateBeijing Syntech Laser APOLLO V+ Medical Platform Recalled for Missing Label
FDA (Devices) · 2018-05-09
- LowBeijing Syntech Laser Trixel 11 CO2 Laser Recalled for Missing Label
FDA (Devices) · 2018-05-09
- ModerateBeijing Syntech Laser UL C02 Laser surgical lasers recalled for missing label
FDA (Devices) · 2018-05-09
- LowBeijing Syntech Laser Diode Surgical Lasers Recalled for Missing Certification Label
FDA (Devices) · 2018-05-09
- ModerateBeijing Syntech Laser Trixel C02 Laser Recalled for Missing Certification Label
FDA (Devices) · 2018-05-09
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateGE Discovery MR950 MRI Systems Recalled for Missing Laser Labels
FDA (Devices) · 2015-05-13
- HighYamaha Optical Inspection Systems Recalled for Missing Laser Safety Certification Label
FDA (Devices) · 2024-05-29
- ModerateChina Daheng Recalls Denlase and Penlase Dental Laser Systems for Missing Calibration Procedures
FDA (Devices) · 2014-03-26
- ModerateNidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label
FDA (Devices) · 2014-08-06
- HighOMTech Desktop Laser Engraver recalled for missing safety interlocks
FDA (Devices) · 2024-06-19
- ModerateInova Lasers Recalls Class IV New Era Medical Laser Devices
FDA (Devices) · 2020-11-25