FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (China)
FDA refused entry of collagen dermal implants from China on Oct 23, 2026.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated October 23, 2026, in the Aesthetic Injectables category.
An import refusal marks a shipment the FDA stopped at the U.S. border as violative — the gray-market corridor a med spa must never source injectables from. Foreign, unapproved, or misbranded product refused at import is exactly what surfaces when a practice buys outside verified US-licensed 503A/503B or FDA-registered channels.
- Type
- FDA Import Refusal
- Jurisdiction
- Federal
- Category
- Aesthetic Injectables
- Recorded
- October 23, 2026
What this means for your practice — the step to take, the deadline to calendar or the supplier detail to check, where the change calls for one — is in the member "what to do" below. This page is the free record of what changed and why it matters.
What to do
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The FDA record
- Firm
- EKAI ELECTRONIC TECHNOLOGY CO LT
- Origin
- Guangzhou, China
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Oct 23, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3042229403
- FDA shipment ID
- 1FX-6034189-9/10002/1
Why FDA refused it
Misbranding502(a), 502(f)(1), 801(a)(3), MISBRANDING
The article appears to be a device which requires a prescription from your doctor.
Misbranding502(c), 801(a)(3); MISBRANDING
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
FDA charge codes on this record: 2480 (Misbranding) · 336 (Misbranding) · 9999970 (no public definition) · 9999973 (no public definition) · 9999974 (no public definition) · 9999976 (no public definition). Definitions via the FDA Refusal Charges Reference.
Verify at FDA
FDA doesn’t publish a page per refusal. Open the FDA Import Refusals database and search by shipment ID 1FX-6034189-9/10002/1 (or firm FEI 3042229403), refused Oct 23, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · EKAI ELECTRONIC TECHNOLOGY CO LT · Guangzhou · plastic-surgery device · refused as misbranding
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