Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation
Inter-Med Llc is recalling 768 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a potential material degradation rather than a confirmed acute health risk.
Plain-English summary
Inter-Med Llc is recalling 768 units of Vista Dental Products Sodium Hypochlorite - 6%, 3mL Pre-filled Syringes (REF 502350). The affected lots are identified by UDI (01)10818207020458 and lot/work order numbers 20190197, 20190723, 20190834, 20190862, and 20190952.
The recall was initiated because the syringes may contain an incorrect bung made of latex-free isoprene rubber. After prolonged storage and exposure to the contained bleach solution, the rubber bung may degrade due to chemical interaction. The affected products were distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia.
Healthcare providers and consumers should check their inventory for the specific lot numbers and UDI listed above. If the product matches the recalled description, it should be removed from use and returned to the distributor or manufacturer.
The recalled product
- Product
- Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
- Manufacturer
- Inter-Med Llc
- Category
- Medical Device — Dental Supplies
- Hazard
- Affected units
- 768
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Inter-Med Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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