3% NaOCL Sodium HypochloriteRecalls & reported problems across all models
Vista Dental · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of 3% NaOCL Sodium Hypochlorite by Vista Dental in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
3% NaOCL Sodium Hypochlorite recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 27, 2019Terminated
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-0015-2020 · Root cause: Process control · Recall details · FDA record ↗
- Jun 27, 2019Terminated
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-0013-2020 · Root cause: Process control · Recall details · FDA record ↗
3% NaOCL Sodium Hypochlorite models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3% NaOCL Sodium Hypochlorite 502355Cleanser, Root Canal1 recall0 reports
- 3% NaOCL Sodium Hypochlorite 502315Cleanser, Root Canal1 recall0 reports
Other Vista Dental products
All Vista Dental devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page