CLASS II Device recall · Reported 9 Oct 2019 · FDA Enforcement Report
Vista Dental Products CanalClean Endodontic Irrigation Kit recalled
Inter-Med is recalling Vista Dental Products CanalClean Endodontic Irrigation Kit - Chlor-XTRA - SmearOFF + +. The recall was initiated on 27 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0011-2020
- FDA event ID
- 83435
- Recalling firm
- Inter-Med, Racine, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2019
- FDA classified
- 1 Oct 2019
- Reported
- 9 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Dental Devices
Timeline
| 27 Jun 2019 | Recall initiated by company | |
| 1 Oct 2019 | Classified by FDA | +96 days |
| 9 Oct 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Where it was distributed
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
No UDI Lot/Work Order Numbers: 2018-1192 2018-1473 2018-1742 2018-1999 2018-2386 2018-2741 2019-0047
Where was it sold?
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 83435This product is part of a recall event; the main page for the event is Vista Dental Products Sodium Hypochlorite - 6%, QTY recalled.
More recalls from Inter-Med
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit recalled | Inter-Med | Packaging Defects | Nationwide |
| Device | CLASS II | Vista Dental Products Chlor-XTRA - Prefilled Syringes, QTY recalled | Inter-Med | Foreign Material | WI |
| Device | CLASS II | Vista Dental Products Chlor-XTRA - Prefilled Syringes, QTY recalled | Inter-Med | Foreign Material | WI |
| Device | CLASS II | Vista Dental Products Sodium Hypochlorite recalled by Inter-Med | Inter-Med | Foreign Material | WI |
| Device | CLASS II | Vista Dental Products 3% Sodium Hypochlorite recalled by Inter-Med | Inter-Med | Foreign Material | WI |
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| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
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