Violation Code: 126
FDA Violation
Charge Code: FAILS STD
Violation Details
- Violation Code (ASC ID)
- 126
- Charge Code
- FAILS STD
- Description
- The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
- Legal Section
- 501(e), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Ansell Shah Alam Sdn Bhd | Selangor Darul Ehsan, MALAYSIA | 19 |
| 2 | Cynosure, LLC | Westford, UNITED STA | 17 |
| 3 | Smiths Healthcare Manufacturing S.A. de C.V. | Tijuana, MEXICO | 10 |
| 4 | Albaad Fem | Caesarea, ISRAEL | 9 |
| 5 | Grand Work Plastic Products Co., Ltd. | Zanhuang City, CHINA | 8 |
| 6 | Track Of Surgical | Sialkot, PAKISTAN | 8 |
| 7 | Teletronica S A De C V | Tijuana, MEXICO | 7 |
| 8 | MONOKEL EYEWEAR | Norrkoping, SWEDEN | 7 |
| 9 | LUMENTUM | Shenzhen, CHINA | 7 |
| 10 | Hichance Industries Limited | Yangzhou, CHINA | 6 |
| 11 | HONSUN (NANTONG) Co., Ltd. | Nantong City, CHINA | 6 |
| 12 | Plasticos y Materias Primas, S.A. de C.V. | Guadalajara, MEXICO | 6 |
| 13 | Gea Sarl Dba Itl | Molsheim, FRANCE | 6 |
| 14 | Cardinal Health (Kenmex Medical Specialties) | Tijuana, MEXICO | 6 |
| 15 | Siemens Ag | Erlangen, GERMANY | 6 |
| 16 | Zhongshan City Newwish Metal & Electronical Factory | Zhongshan City, CHINA | 5 |
| 17 | SHANGHAI XINDUN TRADE CO LTD | Shanghai, CHINA | 5 |
| 18 | Ge Medical | Freiburg im Breisgau, GERMANY | 5 |
| 19 | Hako Med Gmbh | Karlsruhe, GERMANY | 5 |
| 20 | GENIUS CHIP (SHEN ZHEN) LIMITED | Shenzhen, CHINA | 5 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/5/2025 | DENSITOMETER, BONE 90KGI | NAUTIUS INCUNITED STA |
| 11/10/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | FOTONA D.O.O.SLOVENIA |
| 5/29/2025 | NEEDLE, HYPODERMIC, SINGLE LUMEN 80FMI | Becton Dickinson And CompanyUNITED STA |
| 5/9/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | 2DSCANNER L PGREECE |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | LUMENTUMCHINA |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | LUMENTUMCHINA |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | LUMENTUMCHINA |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | LUMENTUMCHINA |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | LUMENTUMCHINA |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | SANMINA-SCI OPTICALCHINA |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | SANMINAMEXICO |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | LUMENTUMCHINA |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | FABRINETTHAILAND |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | FABRINETTHAILAND |
| 4/22/2025 | FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER 95RFN | FABRINETTHAILAND |
Frequently Asked Questions
What is FDA violation code 126?
126 is an FDA violation code that indicates: "The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.". This violation is based on 501(e), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 126?
According to FDA Import Refusal data, there have been 702 import refusals issued for violation code 126, affecting 483 unique firms.
When was the most recent refusal for violation 126?
The most recent import refusal for violation 126 was on December 5, 2025.
What products are commonly refused for violation 126?
Products commonly refused under violation 126 include: DENSITOMETER, BONE, GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL, NEEDLE, HYPODERMIC, SINGLE LUMEN, FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 126?
Violation code 126 is based on 501(e), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.