Chlor-XTRA 503850Recalls & reported problems
Vista Dental · Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation, debridement and cleansing of root canals during and after instrumentation. 12ml pre-filled syringes. · Class U
All models of Chlor-XTRA (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jun 27, 2019Class IITerminated
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
Z-0017-2020 · Root cause: Process control · Recall details · FDA record ↗
Other Cleanser, Root Canal devices
- 6% NaOCL Sodium Hypochlorite 502300Vista Dental · Cleanser, Root Canal1 recall0 reports
- Chlor-XTRA 503825Vista Dental · Cleanser, Root Canal1 recall0 reports
- 3% NaOCL Sodium Hypochlorite 502315Vista Dental · Cleanser, Root Canal1 recall0 reports
- 6% NaOCL Sodium Hypochlorite 502350Vista Dental · Cleanser, Root Canal1 recall0 reports
- 3% NaOCL Sodium Hypochlorite 502355Vista Dental · Cleanser, Root Canal1 recall0 reports
- Brasseler USA 5028425U0Peter Brasseler Holdings, LLC · CLEANSER, ROOT CANAL2 reports
- Q-Mix QMIX60MLTulsa Dental Products LLC · CLEANSER, ROOT CANAL1 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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