Diversatek Healthcare ZAN-BG-44Recalls & reported problems
Diversatek Healthcare, Inc. · Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric & Esophageal) · 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 00816734022283), received between Jul 7, 2026 and Jul 7, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- 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.
MalfunctionJul 7, 2026No Apparent Adverse Event
PER MAUDE ADVERSE EVENT REPORT NUMBER MW5188839: IT WAS REPORTED THAT THE ZEPHR REFLUX PROBE MALFUNCTIONED AND COULD NOT DOWNLOAD THE STUDY. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND IT WAS CONFIRMED BY FURTHER FOLLOW UP TO THE REPORTER THAT THERE WAS NO PATIENT HARM. THE STUDY IS DOWNLOADED AFTER PATIENT INTERACTION, AND THE PATIENT IS NO LONGER INVOLVED. DIVERSATEK HEALTHCARE ACKNOWLEDGES RECEIPT OF THE FDA MEDWATCH REPORT REFERENCED ABOVE. UPON RECEIPT, THE REPORT WAS EVALUATED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25739265 ↗
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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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