Maxi-probe Irrigation Needle MAXP301TRecalls & reported problems
Tulsa Dental Products LLC · Syringe Probe:100 ProRinse 30g · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D716MAXP301T1), received between Apr 19, 2023 and Sep 19, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break9
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PRORINSE IRRIGATION PROBE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20263787 ↗MalfunctionJun 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PRO-RINSE 30G MAXP301T PROBE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17208701 ↗MalfunctionApr 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A PRO-RINSE 30G MAXP301T BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823898 ↗MalfunctionApr 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A PRO-RINSE 30G MAXP301T BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823668 ↗MalfunctionApr 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A PRO-RINSE 30G MAXP301T BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823554 ↗MalfunctionApr 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PRO-RINSE 30G MAXP301T BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823461 ↗MalfunctionApr 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PRO-RINSE 30G MAXP301T BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823379 ↗MalfunctionApr 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PRO-RINSE 30G MAXP301T BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823233 ↗MalfunctionApr 19, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT 3 PRO-RINSE IRRIGATION PROBES BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16770508 ↗
Other SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING devices
- VDW Eddy Flexcanula 21419Produits dentaires S.A. · Syringe, Periodontic, Endodontic, Irrigating55 reports
- Henry Schein 5701403Henry Schein, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
- Henry Schein 5701401Henry Schein, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
- Monoject 1180327114ECardinal Health, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.