Moxi S7-R (amber)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613389770568), received between Dec 17, 2025 and Dec 26, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT BLISTERING BEHIND THE EAR WAS OBSERVED IN A PATIENT. ENT HAS SET THE PATIENT ON MEDICATION, STEROID CREAM. THE PATIENT WAS FITTED WITH THE DEVICE ON (B)(6) 2025 AND CSHELLS ON (B)(6) 2025. THE PATIENT HAD SEEN THE BLISTERING ON SKIN BEHIND EAR ON (B)(6) 2025 BUT HE DIDN'T GO TO MD UNTIL FEW DAYS AGO. THE PATIENT STARTED CREAM RECENTLY. MD FELT THERE MAY BE LEAKAGE FROM AID AND REQUESTED DEVICE REPLACEMENT. IT WAS SAID THE AIDS WERE SENT IN FOR REPAIR WITH NEW HOUSING AND CSHELL FOR REMAKE. IT WAS REPORTED THE ISSUE IS ONLY BEHIND ONE EAR. THE OTHER EAR WAS REPORTED FINE. THE EAR WAS PUT ON REST TO LET IT HEAL. THE PATIENT WOULD BE WITHOUT ONE AID UNTIL THE EAR HEALS. PLANNED WAS A RETURN TO MD FOR CLEARANCE FOLLOWED BY FITTING WITH REPAIRED AID. PATIENT HAS ALLERGY TO NICKEL BUT NO OTHER THINGS.

  Patient problems: Blister; Hypersensitivity/Allergic reaction

  MAUDE report 23901292 ↗
• InjuryDec 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT BLISTERING BEHIND THE EAR WAS OBSERVED IN A PATIENT. ENT HAS SET THE PATIENT ON MEDICATION, STEROID CREAM. THE PATIENT WAS FITTED WITH THE DEVICE ON (B)(6) 2025 AND CSHELLS ON (B)(6) 2025. THE PATIENT HAD SEEN THE BLISTERING ON SKIN BEHIND EAR ON (B)(6) 2025 BUT HE DIDN'T GO TO MD UNTIL FEW DAYS AGO. THE PATIENT STARTED CREAM RECENTLY. MD FELT THERE MAY BE LEAKAGE FROM AID AND REQUESTED DEVICE REPLACEMENT. IT WAS SAID THE AIDS WERE SENT IN FOR REPAIR WITH NEW HOUSING AND CSHELL FOR REMAKE. IT WAS REPORTED THE ISSUE IS ONLY BEHIND ONE EAR. THE OTHER EAR WAS REPORTED FINE. THE EAR WAS PUT ON REST TO LET IT HEAL. THE PATIENT WOULD BE WITHOUT ONE AID UNTIL THE EAR HEALS. PLANNED WAS A RETURN TO MD FOR CLEARANCE FOLLOWED BY FITTING WITH REPAIRED AID. PATIENT HAS ALLERGY TO NICKEL BUT NO OTHER THINGS.

  Patient problems: Blister; Hypersensitivity/Allergic reaction

  MAUDE report 23827167 ↗