DentaPure 365-Day Independent Water Bottle Cartridge *DP365B10Recalls & reported problems
Crosstex International, Inc. · Water Purification Bottle Cartridge · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50732224005503), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT PATIENTS EXPERIENCED AN "IODINE TASTE" IN THEIR MOUTH AND "FELT SICK" FROM THE DENTAPURE CARTRIDGE ATTACHED TO THEIR WATERLINE. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17737295 ↗
Other Unit, operative dental devices
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- NA 5100015270Stryker Corporation · UNIT, OPERATIVE DENTAL75 reports
- TPS 5100004000Stryker Corporation · UNIT, OPERATIVE DENTAL50 reports
- NA 5100015252Stryker Corporation · UNIT, OPERATIVE DENTAL42 reports
- TPS 5100008000Stryker Corporation · UNIT, OPERATIVE DENTAL22 reports
- TPS 5100131000Stryker Corporation · UNIT, OPERATIVE DENTAL17 reports
- TPS 5100007000Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
- NA 5100015272Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
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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