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Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc.: 148 FDA recall reports
Every medical device recall the FDA has published for Fresenius Medical Care Holdings, Inc.. The fault, and how the agency graded it.
148Reports
19Class I
85Ongoing
2026-07-15Most recent
19 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD P
Z-2702-2026 · Class II · reported 2026-07-15 · Ongoing
- Why it was recalled
- Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
- Product
- 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.
- How much
- 113,544 units (4,731 cases)
Bicarby Dialysate; Model number: RFP-400-G;
Z-2401-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Where it went
- Domestic: TX.
- How much
- 4752
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Z-2321-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
- Product
- Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
- Where it went
- US Nationwide distribution in the states of NY, TN and TX.
- How much
- 1,756,108 units
5008X CAREsystem +CLiC +CDX;
Z-0936-2026 · Class II · reported 2025-12-24 · Ongoing
- Why it was recalled
- Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
- Product
- 5008X CAREsystem +CLiC +CDX;
- Where it went
- Domestic: LA, MA, MN;
- How much
- 115 units
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 05003
Z-0041-2026 · Class II · reported 2025-10-15 · Ongoing
- Why it was recalled
- To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
- Product
- Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
- Where it went
- US Nationwide distribution.
- How much
- 172,494,732 units (14,374,561 cases @ 12 units per case)
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF
Z-1992-2025 · Class II · reported 2025-06-25 · Ongoing
- Why it was recalled
- Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
- Product
- 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.
- Where it went
- US Nationwide distribution in the state of Massachusetts.
- How much
- Model Number, Cases (Eaches): 03-5100-7, 76 (1,824); 03-5100-7C, 5 (120); 03-5150-2, 8 (192)
Dialyzer Optiflux 160NRe
Z-0801-2025 · Class II · reported 2025-01-15 · Ongoing
- Why it was recalled
- Potential for internal blood leaks due to cracked polyurethane
- Product
- Dialyzer Optiflux 160NRe
- Where it went
- Nationwide Distribution.
- How much
- 5,351 cases (64,212 dialyzers)
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed
Z-3124-2024 · Class II · reported 2024-09-18 · Ongoing
- Why it was recalled
- Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
- Product
- Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
- Where it went
- US Nationwide. Canada.
- How much
- 3,718 systems
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev
Z-2344-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 17 Units
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev
Z-2347-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 6 units
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Z-2340-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 372 units
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Z-2343-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 1,156 units
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Z-2341-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 531 units
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev
Z-2346-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 2 units
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Z-2342-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 20 units (all OUS)
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Z-2345-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Where it went
- Domestic: Nationwide Distribution. International: Canada.
- How much
- 1 unit
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Par
Z-2141-2024 · Class II · reported 2024-06-19 · Ongoing
- Why it was recalled
- Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
- Product
- US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
- Where it went
- US Nationwide distribution in the states of AL, IN, AK, WI.
- How much
- 4 units
Blood Pump Rotor, Model Number: F40015481 Rev A
Z-1866-2024 · Class II · reported 2024-05-29 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- Blood Pump Rotor, Model Number: F40015481 Rev A
- Where it went
- US Nationwide distribution.
- How much
- 45,880 components
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Re
Z-1868-2024 · Class II · reported 2024-05-29 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Where it went
- US Nationwide distribution.
- How much
- 12,292 units
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Re
Z-1869-2024 · Class II · reported 2024-05-29 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Where it went
- US Nationwide distribution.
- How much
- 334 units
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Re
Z-1867-2024 · Class II · reported 2024-05-29 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Where it went
- US Nationwide distribution.
- How much
- 931 units
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Re
Z-1870-2024 · Class II · reported 2024-05-29 · Ongoing
- Why it was recalled
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
- Where it went
- US Nationwide distribution.
- How much
- 11,371 units
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) res
Z-1822-2024 · Class II · reported 2024-05-22 · Ongoing
- Why it was recalled
- Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
- Product
- Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
- Where it went
- US Nationwide distribution.
- How much
- 88 units
Class I
stay-safe /Luer Lock Adapter 4 in
Z-1324-2024 · Class I · reported 2024-04-03 · Ongoing
- Why it was recalled
- The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Product
- stay-safe /Luer Lock Adapter 4 in
- Where it went
- Domestic: Nationwide Distribution.
- How much
- 828,954 eaches
Class I
stay-safe /Luer Lock Catheter Ext. 18 in
Z-1326-2024 · Class I · reported 2024-04-03 · Ongoing
- Why it was recalled
- The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Product
- stay-safe /Luer Lock Catheter Ext. 18 in
- Where it went
- Domestic: Nationwide Distribution.
- How much
- 479,978 eaches
Class I
stay-safe /Luer Catheter Ext. 6 in
Z-1327-2024 · Class I · reported 2024-04-03 · Ongoing
- Why it was recalled
- The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Product
- stay-safe /Luer Catheter Ext. 6 in
- Where it went
- Domestic: Nationwide Distribution.
- How much
- 105,700 eaches
Class I
stay-safe /Luer Lock Catheter Ext. 12 in
Z-1325-2024 · Class I · reported 2024-04-03 · Ongoing
- Why it was recalled
- The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Product
- stay-safe /Luer Lock Catheter Ext. 12 in
- Where it went
- Domestic: Nationwide Distribution.
- How much
- 663,221 eaches
Class I
stay-safe /Safe Lock Catheter Ext. 12 in
Z-1323-2024 · Class I · reported 2024-04-03 · Ongoing
- Why it was recalled
- The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Product
- stay-safe /Safe Lock Catheter Ext. 12 in
- Where it went
- Domestic: Nationwide Distribution.
- How much
- 114,982 eaches
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Z-0619-2024 · Class III · reported 2024-01-03 · Ongoing
- Why it was recalled
- Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
- Product
- Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
- Where it went
- US Nationwide distribution in the states of AL, CA, FL, IL, IN, LA, MI, MO, MT, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA.
- How much
- 149 US
Stay Safe Cap
Z-0507-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Updating the labeling to include additional warnings and contraindications for potential side effects.
- Product
- Stay Safe Cap
- Where it went
- US Nationwide distribution.
- How much
- 18,236,160 eaches
Showing the 30 most recent of 148. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls