RenuvionRecalls & reported problems across all models
Apyx Medical Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 0
We found 4 models of Renuvion by Apyx Medical Corporation in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2020 and Dec 5, 2025 — classified as 34 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (16 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Renuvion problems
Device problems
- Patient Device Interaction Problem16
- Use of Device Problem13
- Insufficient Device Problem Information11
- Improper or Incorrect Procedure or Method5
- Break3
- Use of Incorrect Control/Treatment Settings3
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Burn(s)10
- Full thickness (Third Degree) Burn9
- Scar Tissue5
- Foreign Body In Patient4
- Pneumothorax3
- Adhesion(s)2
- Blister2
- Nerve Damage2
Renuvion models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Renuvion APYX-27-TPElectrosurgical, Cutting & Coagulation & Accessories14 reports
- Renuvion APYX-15-TPElectrosurgical, Cutting & Coagulation & Accessories11 reports
- Renuvion APYX-RS3Electrosurgical, Cutting & Coagulation & Accessories5 reports
- Renuvion® APYX-270BPPElectrosurgical, Cutting & Coagulation & Accessories4 reports
Recent Renuvion adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Fracture; Fracture
THE TIP OF A HANDPIECE BROKE INTRAOPERATIVELY AND REMAINED IN THE PATIENT DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.
Patient problems: Foreign Body In Patient
MAUDE report 23733249 ↗InjuryJun 7, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
THE PATIENT APPEARED TO EXPERIENCE SUBCUTANEOUS EMPHYSEMA WITH DROP IN PERIPHERAL OXYGEN SATURATION DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT. THE PATIENT APPEARED TO EXPERIENCE SUBCUTANEOUS EMPHYSEMA WITH DROP IN PERIPHERAL OXYGEN SATURATION DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.
Patient problems: Low Oxygen Saturation; Pain; Pneumothorax
MAUDE report 22162119 ↗InjuryApr 25, 2025Break; Break
THE PATIENT RECEIVED A FULL THICKNESS BURN ON THE MEDIAL, DISTAL THIGH AND A SEGMENT OF THE HANDPIECE IS BELIEVED TO HAVE BECOME DISLODGED AND WAS RETAINED IN THE PATIENT DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.
Patient problems: Foreign Body In Patient; Full thickness (Third Degree) Burn
MAUDE report 21913515 ↗InjuryMar 3, 2025Self-Activation or Keying; Self-Activation or Keying
THE PATIENT WAS BURNED BY THE UNPROMPTED ACTIVATION OF AN UNIDENTIFIED MONOPOLAR HANDPIECE DURING A PROCEDURE IN WHICH AN APYX GENERATOR WAS USED.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 21510528 ↗InjuryFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT PRESENTED WITH SCAR CONTRACTURES AFTER A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.
Patient problems: Scar Tissue; Skin Discoloration
MAUDE report 21396961 ↗InjuryAug 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT PRESENTED WITH A BURN ON THEIR NECK / CHIN / SUBMENTAL AREA 2 WEEKS AFTER A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.
Patient problems: Burn(s)
MAUDE report 19920015 ↗InjuryMay 20, 2024Use of Device Problem; Use of Device Problem
THE PATIENT SUSTAINED A BURN ON THEIR ARM AFTER A SUBDERMAL COAGULATION PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.
Patient problems: Burn(s); Scar Tissue
MAUDE report 19353719 ↗InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT SUSTAINED A DEEP PARTIAL-THICKNESS (SECOND-DEGREE) BURN WHICH PROGRESSED INTO A FULL-THICKNESS (THIRD-DEGREE) BURN ON THEIR NECK AFTER A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 19292107 ↗InjuryMar 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT SUSTAINED A DEEP PARTIAL-THICKNESS (SECOND-DEGREE) BURN WHICH PROGRESSED INTO A FULL-THICKNESS (THIRD-DEGREE) BURN ON THEIR RIGHT INNER THIGH AFTER MICROAIRE POWER ASSISTED LIPOSUCTION (PAL) WAS PERFORMED AND IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL PROCEDURE.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 19008336 ↗InjuryMar 22, 2024Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method
THE PATIENT IS EXPERIENCING HYPER/HYPOPIGMENTATION OF THE NECK APPROXIMATELY SIX MONTHS POST-OPERATIVELY AFTER MICROAIRE POWER ASSISTED LIPOSUCTION (PAL) WAS PERFORMED AND IN WHICH DERMAL RESURFACING WAS PERFORMED WITH A RENUVION HANDPIECE AS PART OF THE OVERALL SURGICAL PROCEDURE.
Patient problems: Hyperpigmentation; Hypopigmentation
MAUDE report 18963279 ↗InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A FEMALE PATIENT EXPERIENCED A BURN TO THEIR JAW IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL PROCEDURE.
Patient problems: Burn(s)
MAUDE report 18260113 ↗InjuryOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT STATES PROCEDURE WAS OVER A YEAR AGO. BILATERAL NUMBNESS/TINGLE TO ARMS WRIST TO ARMPIT. NO HAND NUMBNESS. PATIENT STATES SENSATION INTACT TO HANDS.
Patient problems: Nerve Damage
MAUDE report 17995649 ↗InjuryMar 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
AN APYX MEDICAL SALES REPRESENTATIVE REPORTED ON 13FEB2023 THAT THEY RECEIVED A REPORT FROM (B)(6) COSMETIC SURGERY INDICATING A PATIENT EXPERIENCED BURNS AFTER A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2022 IN WHICH RENUVION WAS ALSO USED AS PART OF THE OVERALL SURGICAL PROCEDURE. APYX MEDICAL CONTACTED THE OFFICE ON 01MAR2023. THE SURGEON STATED THERE WAS NO DEVICE MALFUNCTION BUT THAT THEY BELIEVE RENUVION, USED IN CONJUNCTION WITH VASER LIPOSUCTION, MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S BURNS.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 16601548 ↗InjuryDec 22, 2022Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
AN APYX MEDICAL SALES REPRESENTATIVE REPORTED ON 01DEC2022 THAT THEY RECEIVED A REPORT FROM DR. KEVIN HANZ OF HANZ AESTHETIC PLASTIC SURGERY INDICATING A PATIENT EXPERIENCED BURNS AFTER A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2022 IN WHICH RENUVION WAS ALSO USED AS PART OF THE OVERALL SURGICAL PROCEDURE.. APYX MEDICAL CONTACTED THE SURGEON ON 15DEC2022. THE SURGEON STATED THERE WAS NO DEVICE MALFUNCTION BUT THAT THEY BELIEVE RENUVION MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S BURNS.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 16036357 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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