INTEGO pro CS ambidextrous 6591866Recalls & reported problems
SIRONA Dental Systems GmbH · Treatment Center INTEGO pro CS ambidextrous with disinfection · 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 E27665918660), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
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.
MalfunctionJan 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER ALLEGED THAT BLOOD CAME FROM THE CUP FILLER INTO THE PATIENT'S DRINKING CUP. THE PATIENT, USER OR THIRD-PARTY WERE NOT INJURED. THE PATIENT DID NOT DRINK FROM THE DRINKING CUP. IF THE TREATMENT CENTER IS ASSEMBLED AND MAINTAINED CORRECTLY, IT IS TECHNICALLY IMPOSSIBLE THAT BLOOD CAN ENTER THE WATER-WAY OF THE CUP WATER. THERE IS AN ON-GOING ONSITE INVESTIGATION OF THIS DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179758 ↗
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- TPS 5100004000Stryker Corporation · UNIT, OPERATIVE DENTAL50 reports
- NA 5100015252Stryker Corporation · UNIT, OPERATIVE DENTAL42 reports
- TPS 5100008000Stryker Corporation · UNIT, OPERATIVE DENTAL22 reports
- TPS 5100131000Stryker Corporation · UNIT, OPERATIVE DENTAL17 reports
- TPS 5100007000Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
- NA 5100015272Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
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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