Device recall: 2008T Hemodialysis SYS, with CDX

Class I FDA enforcement event 92788. Recall start date: 6 Sep 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Potential PCBA leaching from tubing of hemodialysis machines.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Fresenius Medical Care Holdings, Inc. started this device recall on 6 Sep 2023. The firm address in the FDA record is in Waltham, MA. FDA put the recall in Class I. FDA event 92788 has 8 product records. The first FDA enforcement report date is 18 Oct 2023. The record gives the status Ongoing.

FDA enforcement report The 8 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Domestic: Nationwide Distribution.

Recalling firm

Fresenius Medical Care Holdings, Inc., Waltham, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

8 product records in the event.

FDA event 92788: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0028-2024	2008T Hemodialysis SYS, with CDX	703 units	Class I	Ongoing	18 Oct 2023
Z-0029-2024	2008T Hemodialysis System without CDX	733 units	Class I	Ongoing	18 Oct 2023
Z-0030-2024	2008T Hemodialysis System w/Bibag	733 units	Class I	Ongoing	18 Oct 2023
Z-0031-2024	2008T GEN 2 Bibag without CDX	733 units	Class I	Ongoing	18 Oct 2023
Z-0032-2024	2008T HD SYS. CDX BLUESTAR	733 units	Class I	Ongoing	18 Oct 2023
Z-0033-2024	2008T HD SYS. CDX W/BIBAG BLUESTAR	733 units	Class I	Ongoing	18 Oct 2023
Z-0034-2024	2008T HD SYS. W/O CDX BLUESTAR	733 units	Class I	Ongoing	18 Oct 2023
Z-0035-2024	2008T HD SYS. W/O CDX W/BIBAG BLUESTAR	733 units	Class I	Ongoing	18 Oct 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class I: 10%
Product records in this event: 8Median of the firm: 1
Events of the firm on the register: 66

Other events of the firm

Other FDA enforcement events of Fresenius Medical Care Holdings, Inc.
Initiated	Product (first record)	Type	Class	Records
12 May 2026	Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;	Device	Class II	1
11 May 2026	5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Stan	Device	Class II	1
7 May 2026	Bicarby Dialysate; Model number: RFP-400-G;	Device	Class II	1
6 Apr 2026	DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1	Drug	Class II	2
25 Oct 2025	5008X CAREsystem +CLiC +CDX;	Device	Class II	1
29 Aug 2025	Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX	Device	Class II	1
27 May 2025	0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,	Drug	Class II	1
29 Apr 2025	5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,	Device	Class II	1
5 Dec 2024	Dialyzer Optiflux 160NRe	Device	Class II	1
8 Aug 2024	Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 S	Device	Class II	1

Fresenius Medical Care Holdings, Inc.: all 66 events

Official channels

FDA enforcement report Z-0028-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 92788. https://recallregister.com/fda/i/92788/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Domestic: Nationwide Distribution.
What quantity of product is in FDA event 92788?: The event has 8 product records. The first record gives this quantity: 703 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 10% of the 917 device events that started in 2023 are in Class I.