RHA® Redensity RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2 (REF 940056/01)Recalls & reported problems
Teoxane SA · "One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233794) is defined as unit of sales and identified with a serial number." · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640173233763), received between Jun 17, 2025 and Jun 17, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Granuloma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS CASE OCCURED OUTSIDE OF THE USA IN POLAND. THE POLISH SUBSIDIARY NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT ON 07-APR-2025. DURING TEOXANE WORKSHOP IN POLAND ON (B)(6) 2024, A FEMALE PATIENT WAS INJECTED WITH THE FOLLOWING PRODUCTS: 0.1 ML OF RHA 1 IN THE TEAR TROUGH, USING THE NEEDLE PROVIDED IN THE BOX (CURRENT COMPLAINT). 1.2 ML OF RHA 4 IN THE CHEEKS, USING A 22G/50MM CANNULA (RC/2504041). 2.4 ML OF ULTRA DEEP IN THE CHEEKS, USING A 22G/50MM CANNULA (RC/2504042). ON AN UNKNOWN DATE AFTER THE INJECTION, THE PATIENT EXPERIENCED SWELLING IN THE RIGHT TEAR TROUGH, WHERE TEOSYAL RHA 1 WAS INJECTED. IN 2025, THE LOCAL MEDICAL EXPERT WAS CONTACTED AND FOLLOWED UP THE PATIENT. ACCORDING TO THE INFORMATION RECEIVED ON 06-JUN-2025, THE MEDICAL EXPERT RECEIVED THE PATIENT FOR CONSULTATION ON (B)(6) 2025 AND CONFIRMED THE PRESENCE OF PALPABLE, HARD, IMMOBILE, LUMPY LESIONS LOCATED IN THE CENTRAL PART OF THE FACE. THE SYMPTOMS STARTED AROUND ON (B)(6) 2025. IN THE LEFT ZYGOMATIC AND IN TEMPORAL REGION, SOME MASSIVE, COHESIVE, HARD SUBCUTANEOUS LESIONS, IMMOBILE RELATIVE TO THE SURROUNDING TISSUES WERE ALSO OBSERVED. NO OTHER SYMPTOMS WERE REPORTED. AN ULTRASOUND WAS PERFORMED THE SAME
Patient problems: Granuloma
MAUDE report 22235064 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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