MI Paste Plus™ 422621Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D6584226211), received between Sep 22, 2025 and Sep 22, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjurySep 22, 2025Adverse Event Without Identified Device or Use Problem

  ALTHOUGH IT CANNOT BE CONCLUSIVELY DETERMINED THAT THE SYMPTOMS WERE DIRECTLY ATTRIBUTABLE TO MI PASTE PLUS MINT, THE PRODUCT REMAINS A POSSIBLE CONTRIBUTING FACTOR. GIVEN THE PHYSICIAN'S ASSESSMENT THAT THE PATIENT WAS HEADING TOWARD AN ANAPHYLACTIC REACTION, THE EVENT PRESENTS THE POTENTIAL FOR SERIOUS INJURY IF IT WERE TO RECUR. THEREFORE, BASED ON THE SERIOUS NATURE OF THE REACTION, THE POSSIBLE CAUSAL RELATIONSHIP TO THE PRODUCT, AND IN ACCORDANCE WITH 21 CFR 803.3(O)(2) STATED AS FOLLOWS: (1) AN EVENT THAT USER FACILITIES BECOME AWARE OF THAT REASONABLY SUGGESTS THAT A DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR (2) AN EVENT THAT MANUFACTURERS OR IMPORTERS BECOME AWARE OF THAT REASONABLY SUGGESTS THAT ONE OF THEIR MARKETED DEVICES: (I) MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, OR (II) HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE MARKETED BY THE MANUFACTURER OR IMPORTER WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THIS ADVERSE EVENT IS DETERMINED TO BE REPORTABLE. EVEN THOUGH AN ALLERGIC REACTION MAY BE AN EXPECTED SYMPTOM ESPECIALLY FOR PATIENTS WITH MILK

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23109342 ↗
• InjurySep 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PRODUCT ASSOCIATED WITH THIS CASE WAS PURCHASED FROM 2 NON-AUTHORIZED SOURCES. PATIENT HAD A TUBE AND THEN PURCHASED 6 MORE TUBES. HYGIENIST WAS INFORMED AS WELL THESE ARE NON-AUTHORIZED SOURCES. HYGIENIST HAD INITIALLY REFERRED HER TO WALMART.COM AS THE CLINIC DOES NOT OFFER MI PASTE PRODUCTS AND SHE HAD DISCOVERED THAT VIA A GOOGLE SEARCH AS A MEANS TO PURCHASE, UNKNOWING THE FACT THAT THIRD PARTY SELLERS ARE NOT AUTHORIZED TO SELL IT. THERE WERE 2 USES OF THE PRODUCT. ONE EARLIER IN (B)(6), BECAUSE THE INITIAL REACTION SHE EXPERIENCED WAS THOUGHT TO BE RELATED TO POSSIBLY A VIRUS OR SOMETHING ON THAT LINE BECAUSE SHE HAD USED THE PRODUCT PREVIOUSLY WITHOUT INCIDENCE. SHE DECIDED TO TRY IT AGAIN BUT HAD AN EVEN WORSE REACTION. THE PATIENT REQUIRED MEDICAL ATTENTION. IN ADDITION TO THE INFORMATION ATTACHED, THE HYGIENIST DID INFORM ME THAT THE DOCTOR THAT TREATED HER TOLD HER SHE WAS HEADING TOWARDS AN ANAPHYLACTIC STATE, OF WHICH THE PATIENT DID NOT INITIALLY TELL THE HYGIENIST. THE PATIENT'S MD DID INFORM HER TO NEVER USE THE MI PASTE PRODUCTS AGAIN. AT PRESENT TIME THE PATIENT IS FINE AND FINISHING UP WITH HER STEROIDS. ALTHOUGH IT CANNOT BE CONCLUSIVELY DETERMINED THAT THE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23107956 ↗