Fresenius Medical Care Holdings recalls
33 official recalls and safety alerts involving Fresenius Medical Care Holdings since 2022-02, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Fresenius Medical Care Holdings or the relevant agency.
- 2026-07-15
USFresenius Medical Care Holdings, Inc. recalls 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush…
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.
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA,…Official notice →- 2026-06-17
- US
Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate; Model number: RFP-400-G;
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…
- US
Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
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…
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of NY, TN and TX.Official notice → - 2026-05-13
- US
Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,…
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- 2025-12-24
- US
Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;
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.
- 2025-10-15
- US
Fresenius Medical Care Holdings, Inc. recalls Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX…
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…
- 2025-07-02
- US
- 2025-06-25
- US
Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,…
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.
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the state of Massachusetts.Official notice → - 2025-01-15
- US
Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe
Potential for internal blood leaks due to cracked polyurethane
- 2024-09-18
- US
Fresenius Medical Care Holdings, Inc. recalls Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008…
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…
- 2024-07-24
- US
Fresenius Medical Care Holdings, Inc. recalls DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set,…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- 2024-07-17
- US
Fresenius Medical Care Holdings, Inc. recalls RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
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.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution. International: Canada.Official notice → - 2024-06-19
- US
Fresenius Medical Care Holdings, Inc. recalls US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:…
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…
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of AL, IN, AK, WI.Official notice → - 2024-05-29
- US
Fresenius Medical Care Holdings, Inc. recalls Blood Pump Rotor, Model Number: F40015481 Rev A
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.
- 2024-05-22
- US
Fresenius Medical Care Holdings, Inc. recalls Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/…
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…
- 2024-04-03
- US
Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Lock Adapter 4 in
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution.Official notice → - 2024-01-10
- US
- 2024-01-03
- US
Fresenius Medical Care Holdings, Inc. recalls Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of AL, CA, FL, IL, IN, LA, MI, MO,…Official notice → - 2023-12-13
- US
Fresenius Medical Care Holdings, Inc. recalls Stay Safe Cap
Updating the labeling to include additional warnings and contraindications for potential side effects.
- 2023-10-18
- US
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution.Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
There is a potential for blood backfill leakage and foreign material.
- 2023-06-07
- US
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America,…
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
FDA · DrugFresenius Medical Care Holdings, Inc.Product was distributed to 32 clinics in SC, NC and VA.Official notice → - 2022-12-28
- US
Fresenius Medical Care Holdings, Inc. recalls 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare…
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false…
- 2022-12-14
- US
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
FDA · DrugFresenius Medical Care Holdings, Inc.Product was distributed Nationwide in the USA.Official notice → - 2022-11-16
- US
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA…Official notice → - 2022-10-26
- US
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- 2022-09-28
- US
Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius…
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV,…Official notice → - 2022-08-03
- US
Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on…
- 2022-07-20
- US
Fresenius Medical Care Holdings, Inc. recalls NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for…
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
- US
Fresenius Medical Care Holdings, Inc. recalls AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ…
AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device.…
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of NC and WV.Official notice → - 2022-07-13
- US
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream…
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of Texas and Louisiana.Official notice → - 2022-07-06
- US
Fresenius Medical Care Holdings, Inc. recalls Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the state of Pennsylvania.Official notice → - 2022-02-16
- US
Fresenius Medical Care Holdings, Inc. recalls Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours)…
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted…
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ,…Official notice →