FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
FDA refuses entry for collagen implants from South Korea.
What changed & why it matters
Med Spa Radar recorded an FDA import refusal at the federal level, dated July 31, 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
- July 31, 2026
What this means for your specific practice — the exact step to take, the deadline to calendar, or the supplier detail to check — is in the member "what to do" below. This page is the free record of what changed and why it matters.
What to do
Free weekly Brief
Get the changes that matter in plain English, every week — and be alerted when the rules move. No charge.
Members get the full “what to do” on every alert — in real time, for your states. Become a member →
The FDA record
- Firm
- WEDERM
- Origin
- Seoul, South Korea
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Jul 31, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3027190985
- FDA shipment ID
- 1FX-6724044-9/30002/2
Why FDA refused it
Misbranding502(a),(f)(1), 801(a)(3); MISBRANDING
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
FDA charge codes on this record: 84 (Misbranding) · 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-6724044-9/30002/2 (or firm FEI 3027190985), refused Jul 31, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · WEDERM · Seoul · plastic-surgery device · refused as misbranding
Related alerts
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
- FDA import refusal: Lidocaine (Belgium)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Brazil)
- FDA import refusal: Botox (onabotulinumtoxinA) (Ireland)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Vietnam)
- FDA import refusal: Acid, Hyaluronic, Intraarticular (Sweden)
Monitoring, not legal advice.