AH PLUS ROOTCANAL 60620110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI D010606201101), received between Oct 23, 2023 and Nov 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Lack of Effect; Lack of Effect

  IN THIS EVENT IT IS REPORTED THAT AH PLUS EXPORT 3ML CHINA THAT WAS USED IN A ROOT CANAL TREATMENT IN DECEMBER OF 2023 AND NO ABNORMALITIES WERE REPORTED. IN AUGUST OF 2024 THE PATIENT CAME INTO THE HOSPITAL AND REPORTED EXPERIENCING PAIN IN THEIR TEETH. THE DOCTOR FOUND PERIAPICAL PERIODONTITIS, SECONDARY CARIES AND TOOTH DEFECTS. ANOTHER ROOT CANAL WAS DONE ON THE SAME TOOTH. THE PATIENT CURRENTLY HAS NO ABNORMALITIES. A PATIENT REPORTEDLY PRESENTED PAIN ON AN ENDODONTICALLY TREATED TOOTH SEVEN MONTHS AFTER TREATMENT. THEY HAD TO UNDERGO ENDODONTIC RETREATMENT, WHICH LED TO IMPROVEMENT IN SYMPTOMS. THE EVENT DESCRIPTION SUGGESTS A FAILURE OF THE ENDODONTIC TREATMENT, WHICH IS A COMMON COMPLICATION OF ENDODONTIC TREATMENT AND NOT NECESSARILY RELATED TO THE SEALER.

  Patient problems: Pain

  MAUDE report 20783546 ↗
• InjuryOct 4, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  IN THIS EVENT IT IS REPORTED THAT AH PLUS EXPORT 3ML CHINA, THE PASTE WAS THIN AND THE GUTTA-PERCHA POINT CANNOT SOLIDIFY AND THE ROOT CANAL BECAME INFLAMED, REQUIRING SECOND TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 20368134 ↗
• InjuryJun 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT AH PLUS EXPORT 3ML CHINA THAT WAS USED IN TREATMENT ON A PATIENT CAUSED GUM REDNESS AND SWELLING TO THE PATIENT. THE AREA WAS IMMEDIATELY RINSED WITH WATER AND REFILLED. FURTHER INFORMATION REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19546849 ↗
• InjuryOct 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT DURING USE OF AH PLUS EXPORT 3ML CHINA IN ROOT CANAL FILLING; DURING THE FILLING PROCESS THE PATIENT REPORTED GINGIVAL ITCHING AT THE FILLING PLACE, AND THE SYMPTOMS GRADUALLY INTENSIFIED. THERE WAS NO RELIEF AFTER 5 MINUTES OF OBSERVATION. THE FILLING MATERIAL IN THE ROOT CANAL WAS REMOVED, AND THE NORMAL SALINE AND HYDROGEN PEROXIDE WERE WASHED ALTERNATELY. THE PATIENT REPORTED GRADUAL REMISSION OF SYMPTOMS. SUSPECTED ROOT FILLING MATERIAL ALLERGY. APPLIED FILLING MATERIAL TO THE LEFT HAND OF THE PATIENT, GRADUALLY FEEL THE ITCHING AGGRAVATED, AND THEN RINSE AWAY. ZINC OXIDE TEMPORARILY SEALED, A WEEK OF FOLLOW-UP, REPLACE WITH OTHER MATERIALS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17985269 ↗