Isopure Corp recall records

1 reported ongoing

2 records in this archive. Latest source date Jul 26, 2022.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis faciliti...

Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

Class IIReported terminated

Distribution: US Nationwide distribution.

Official source for Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distributi...
FDA device enforcement

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be...

Class IIReported ongoing

Distribution: Domestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK PA TX UT VA WV No foreign distribution.

Official source for Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

Reasons in these listed records

  • Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
  • Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent su...

These examples come from this result page and are not a ranking of every recall reason.

Checking Isopure Corp

Is there a recall on isopure corp right now?

This archive contains 2 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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