FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Canada)
FDA refused entry of Canadian collagen implants; verify your suppliers.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated August 13, 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
- August 13, 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.
Firm inspection: Voluntary Action Indicated
This firm’s most recent FDA inspection was classified Voluntary Action Indicated (VAI) — objectionable conditions FDA expects the firm to correct.
Source: FDA Data Dashboard inspection classifications (most recent, by firm FEI).
What to do
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The FDA record
- Firm
- Prollenium Medical Technologies Inc.
- Origin
- Aurora, Canada
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Aug 13, 2026
- FDA district
- Division of Northern Border Imports
- Firm FEI
- 3004423487
- FDA shipment ID
- SCS-5739620-9/10002/1
Why FDA refused it
Misbranding502(o), 801(a)(3); MISBRANDING
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Misbranding502(o), 801(a)(3); MISBRANDING
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FDA charge codes on this record: 118 (Misbranding) · 3280 (Misbranding). 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 SCS-5739620-9/10002/1 (or firm FEI 3004423487), refused Aug 13, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Prollenium Medical Technologies Inc. · Aurora · plastic-surgery device · refused as misbranding
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