Lower riskMedical device recall · FDA · Published April 20, 2021
Medivators Dialysate Concentrate Recall: Possible Manufacturing Anomaly
Medivators recalls dialysate concentrate for hemodialysis due to potential manufacturing issues that could lead to improper formulation. Affected lots may not meet specifications for safe use in hemodialysis machines.
“Medivators Dialysate Concentrate Recall: Possible Manufacturing Anomaly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62760-medivators-dialysate-concentrate-recall-possible-manufacturing-anomaly. Based on FDA recall #Z-1859-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1859-2021%22&limit=1).
The FDA announced on April 20, 2021, that Medivators, Inc. is recalling Dialysate Concentrate for Hemodialysis due to a manufacturing anomaly that could result in an out-of-specification formulation. The company initiated this voluntary Class II recall affecting 1,381 cases distributed nationwide and in specific states.
How to tell if you have it
Brand: Medivators
Product: Dialysate Concentrate for Hemodialysis-Liquid/Powd
Lot code: 489224
Quantity: 1,381 cases
The hazard
According to the FDA, the lot may have experienced an anomaly during the manufacturing process that could lead to an out of specification concentrate formulation. The product is used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Context
GovInfoNow's records show Medivators, Inc. has one other recall on record since October 9, 2019, involving EndoGator SmartCap Tubing due to inadequate insufflation risks. Other recent recalls of similar products include Diasol 100425-10-DEX100 Dialysis Concentrate Recall (November 5, 2025), Diasol 100325-10-DEX100 Dialysis Concentrate Recall (November 5, 2025), and Bard DuoGlide Dialysis Catheter Recall (May 21, 2026).
How to tell if you have this one
Check for the lot number 489: 489224 on the dialysate concentrate container. This product is used with bicarbonate in hemodialysis machines for kidney treatment.
Brand
Medivators
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for lot number 489224 on the dialysate concentrate container.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Iowa, Minnesota, New York, North Dakota, Ohio, South Dakota, Wisconsin.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1859-2021 (April 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1859-2021 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.