Comfort Plus™ Premium Saliva Ejectors ZWWCPRecalls & reported problems
Crosstex International, Inc. · Saliva Ejectors, White, White · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10732224000678), received between Sep 14, 2020 and Jun 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Rash1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
DISTRIBUTOR REPORTED THAT A PATIENT HAD A REACTION TO A SALIVA EJECTOR. THE PATIENT'S FACE BROKE OUT.
Patient problems: Rash
MAUDE report 22201637 ↗MalfunctionSep 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED A SALIVA EJECTOR TIP DETACHED FROM THE COMFORT PLUS PREMIUM SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. THE TIP WAS NOT SWALLOWED BY THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10532477 ↗
Other Mouthpiece, saliva ejector devices
- Argyle 8881450004Cardinal Health, Inc. · Mouthpiece, saliva ejector9 reports
- Advantage™ Saliva Ejectors ZWWICrosstex International, Inc. · Mouthpiece, saliva ejector1 report
- MEDICOM SAFEBASICS 700AMD Medicom Inc · Mouthpiece, saliva ejector1 report
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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