UltraCal XS 1027Recalls & reported problems
Ultradent Products, Inc. · UltraCal XS Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883205103970), received between Dec 21, 2017 and Dec 21, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON JANUARY 4, 2017, ULTRADENT RECEIVED A LETTER FROM THE FDA DATED (B)(6) 2016 REGARDING A MEDWATCH REPORT SUBMITTED BY AN ORAL SURGEON. IN THE MEDWATCH REPORT, THE ORAL SURGEON STATES THAT HE BEGAN SEEING A PATIENT 6 WEEKS AFTER THE PATIENT'S DENTIST INJECTED THE PRODUCT ULTRACAL XS INTO THE PATIENT'S LOWER INCISOR TOOTH (THE ORAL SURGEON DOES NOT IDENTIFY THE QUANTITY OF ULTRACAL XS INJECTED). THE ORAL SURGEON CLAIMS THAT THE MEDICAMENT EMBOLIZED INTO VESSELS AROUND THE PATIENT'S TOOTH, CAUSING CHIN PAIN, NUMBNESS, AND LOOSENING OF AT LEAST 7 TEETH. THE ORAL SURGEON FURTHER CLAIMS THAT THE PRODUCT IFU DOES NOT PROVIDE INSTRUCTIONS FOR TREATING THIS PROBLEM OR A WARNING ABOUT THIS TYPE OF COMPLICATION. THE ORAL SURGEON DOES NOT CLAIM THAT THE ULTRACAL XS PRODUCT WAS DEFECTIVE, FAULTY, OR OTHERWISE MALFUNCTIONED IN ANY WAY.
Patient problems: Pain
MAUDE report 7139676 ↗
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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