FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
FDA refuses entry of collagen implants from South Korea—verify your suppliers.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated September 3, 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
- September 3, 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
- UNKNOWN
- Origin
- UNKNOWN, South Korea
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Sep 3, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3001137323
- FDA shipment ID
- AEK-0977002-4/10002/1C
Why FDA refused it
Adulteration501(f)(1)(B), 801(a)(3); ADULTERATION
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FDA charge codes on this record: 237 (Adulteration). 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 AEK-0977002-4/10002/1C (or firm FEI 3001137323), refused Sep 3, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · UNKNOWN · UNKNOWN · plastic-surgery device · refused as adulteration
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