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Lower risk Medical device recall · FDA · Published June 27, 2019

Inter-Med Vista Dental Bleach Syringes May Have Degrading Bung

Inter-Med recalls 12-count 3mL pre-filled bleach syringes with potential latex-free rubber bung that may degrade over time, causing safety risks.

🇺🇸 FDA recall #Z-0014-2020Medical deviceInter-Med ›
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Recalling firmInter-Med Llc2200 Northwestern Ave · Racine, WI 53404-2500
✎ GovInfoNow plain-language explainer

Inter-Med is recalling 12 pre-filled 3mL bleach syringes that may have a bung made of a material that degrades over time. This could lead to leaks or improper use of the bleach solution. Read more at govinfonow.com/recall/67552-inter-med-vista-dental-bleach-syringes-may-have-degrading-bung.

Source Summary by GovInfoNow · govinfonow.com/recall/67552-inter-med-vista-dental-bleach-syringes-may-have-degrading-bung · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0014-2020

Cite this page

“Inter-Med Vista Dental Bleach Syringes May Have Degrading Bung.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67552-inter-med-vista-dental-bleach-syringes-may-have-degrading-bung. Based on FDA recall #Z-0014-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0014-2020%22&limit=1).

The FDA announced on June 27, 2019, that Inter-Med Llc is recalling Vista Dental Products Sodium Hypochlorite - 6% pre-filled syringes due to a hazardous bung. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

  • Brand: Inter-Med
  • Product: Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
  • UPC: 10818207020458
  • Lot/Work Order Numbers: 20190197, 20190723, 20190834, 20190862, 20190952
  • Units affected: 768

The hazard

The FDA said the affected lots may be packaged in syringes with 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.

Context

GovInfoNow's records show Inter-Med Llc has one other recall on record since May 27, 2026. Other recent recalls of similar products include Medline Convenience Kits with BD Chl (July 20, 2026) and Medline Convenience Kits (July 20, 2026).

How to tell if you have this one

Check for the product name 'Vista Dental Products Sodium Hypochlorite - 6%', 12-count 3mL pre-filled syringes, and lot numbers 20190197, 20190723, 20190834, 20190862, or 20190952.

  • Brand
    Inter-Med
  • Product
    Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Recall numberProduct, codes & lotsQuantity
Z-0011-2020Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700; No UDI Lot/Work Order Numbers: 2018-1192 2018-1473 2018-1742 2018-1999 2018-2386 2018-2741 2019-0047377 units
Z-0012-2020Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300; Lot/Work Order Numbers: 2018-1348 2018-1585 2018-1586 2018-1852 20182106, UDI (01)10818207020465 20182302, UDI (01)10818207020465 20182458, UDI (01)10818207020465 20190725, UDI (01)10818207020465 20190835, UDI (01)108182070204651992 units
Z-0013-2020Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315; Lot/Work Order Numbers: 2018-1349 2018-1587 2018-1853 20182107, UDI (01)10818207020427 20182303, UDI (01)10818207020427 20182584, UDI (01)10818207020427 20182666, UDI (01)10818207020427 20190199, UDI (01)10818207020427 20190433, UDI (01)10818207020427582 units
Z-0014-2020Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350; UDI (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952768 units
Z-0015-2020Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355; UDI (01)10818207020410 Lot/Work Order Numbers: 20182545 20182665 20190198 20190432 20190724 20190953 20191314445 units
Z-0016-2020Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825; UDI (01)10818207020496 Lot/Work Order Numbers: 20190565 2019110758 units
Z-0017-2020Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850; Lot/Work Order Numbers: 2018-1471 2018-1992 20182211, UDI (01)10818207020502 20182779, UDI (01)10818207020502 20190041, UDI (01)10818207020502 20190309, UDI (01)10818207020502384 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product name, quantity, and lot numbers listed in the recall notice to confirm if your syringes are affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Jun 27, 201912. FDA classified it Class II: Oct 1, 201923. Published in FDA’s Enforcement Report: Oct 9, 201934. FDA terminated the recall: Aug 10, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0014-2020 (June 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0014-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA