RecallReported September 2, 2026
Class II recall by Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
FDA's enforcement report of September 2, 2026 lists a Class II recall by Fresenius Medical Care Renal Therapies Group, LLC of Waltham, MA. Product: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. Status: Ongoing.
On the record
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Location
- Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3017-2026
- Product type
- Devices
- Recall initiated
- 2026-06-30
- Reported by FDA
- 2026-09-02
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
More
Watch Fresenius Medical Care Renal Therapies Group, LLC
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA enforcement reports. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Fresenius Medical Care Renal Therapies Group, LLC.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.