RHA® Redensity RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2 (REF 940056/02)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 07640173234180) 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 07640173234197), received between Mar 30, 2026 and Mar 30, 2026 — 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
- Hypersensitivity/Allergic reaction1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
ALLERGIC REACTION [TYPE I HYPERSENSITIVITY] ([FACE OEDEMA]) RHA REDENSITY TO EACH OF 4 LIP QUADRANTS/LIPS THEMSELF, SUPERFICIAL NFL LINES [OFF LABEL USE]. CASE NARRATIVE: ON 03-MAR-2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT FROM THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED FROM THE INJECTOR, A PATIENT WAS INJECTED ON (B)(6) 2026 WITH RHA REDENSITY AND THE 30G NEEDLES PROVIDED IN THE BOX: IN THE PERIORAL LINES (ABOVE THE UPPER LIP). IN THE LIPS (0.05 - 1 ML TO EACH OF 4 LIP QUADRANTS). IN THE NASOLABIAL FOLD LINES SUPERFICIALLY. THE PATIENT HAD A HISTORY OF ALLERGIES INCLUDING: DUST MITES, BALSAM OF PERU, FORMALDEHYDE, RUBBER ACCELERATORS, LIMONENE, LINALOOL, AND MINOXIDIL. THE PATIENT HAD HISTORY OF OTHER AESTHETIC TREATMENTS: HYDRAFACIALS, IPL, HOLLYWOOD SPECTRA LASER ALTHOUGH NO OTHER FILLER HISTORY. SHE HAS ALSO HAD A FACE LIFT PRIOR TO THE INJECTION. PATIENT'S CONCOMITANT MEDICATION INCLUDED LISINOPRIL, HYDROCHLOROTHIAZID (HCTZ), LIPITOR, PROBIOTICS, AND VITAMIN D. ON (B)(6) 2026, IMMEDIATELY AFTER TREATMENT THE PATIENT HAD A NORMAL POST-PROCEDURE PERI-ORAL SWELLING AND WAS ADVISED TO ICE ON AND OFF THROUGHOUT THE DAY. SHE HAD NO BRUISING, REDN
Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema
MAUDE report 24727969 ↗
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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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