Premier 1006060Recalls & reported problems
Premier Dental Products Company · NITROSPRAY PLUS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D6911006060), received between Dec 8, 2020 and Mar 9, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (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
Device problems
- Free or Unrestricted Flow2
- Misassembly by Users2
- Burst Container or Vessel1
Patient problems
- Blister2
- Cryogenic Burn2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2022Burst Container or Vessel; Burst Container or Vessel
NITROSPRAY UNIT WAS FILLED AND SITTING ON THE COUNTER AND THE LID BLEW OFF. CEILING DAMAGE, THEIR MAINTENANCE STAFF FIXED IT IMMEDIATELY, NO OTHER DAMAGE OR INJURY REPORTED. EVENT OCCURRING 8:05AM (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13713565 ↗InjuryMay 3, 2021Free or Unrestricted Flow; Misassembly by Users; Free or Unrestricted Flow; Misassembly by Users
DUE TO USER ERROR, TWO PATIENTS HAD BLISTERING AFTER TREATMENT. PATIENTS WERE MONITORED FOR HEALING, BOTH BURNS WERE NOT SERIOUS AND DID NOT REQUIRE MEDICAL TREATMENT.
Patient problems: Blister; Cryogenic Burn
MAUDE report 11761062 ↗InjuryDec 8, 2020Free or Unrestricted Flow; Misassembly by Users; Free or Unrestricted Flow; Misassembly by Users
DUE TO USER ERROR, TWO PATIENTS HAD BLISTERING AFTER TREATMENT. PATIENTS WERE MONITORED FOR HEALING, BOTH BURNS WERE NOT SERIOUS AND DID NOT REQUIRE MEDICAL TREATMENT.
Patient problems: Blister; Cryogenic Burn
MAUDE report 10969166 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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