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Sign in to claim this brandFresenius Medical Care Holdings, Inc.
US
Last updated May 24, 2026
What Fresenius Medical Care Holdings, Inc. makes
The company manufactures single-use and reusable components for peritoneal and haemodialysis treatments, including tubing sets, dialysers, concentrates, and extracorporeal waste bags. Their portfolio also covers complete institutional haemodialysis systems and single-use adaptors for peritoneal dialysis catheters, designed for use in both clinical and home-based settings.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates primarily from the United States, adhering to applicable domestic and international regulatory standards for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xxx.xxx
- —
- —
- [email protected]
- Phone
- +1(800)323-5188
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 958291411
Catalogue (92)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Liberty® | 050-87215 | FDA UDI | Class II | Active |
| NaturaLyte | 08-4110-6 | FDA UDI | Class II | Active |
| Optiflux® | 0500318A | FDA UDI | Class II | Unknown |
| CombiSet Twister | 03-2794-0 | FDA UDI | Class II | Active |
| Optiflux® | 0500306E | FDA UDI | Class II | Unknown |
| Premier | 050-30035 | FDA UDI | Class II | Active |
| Liberty® PDx | 050-87220 | FDA UDI | Class II | Active |
| Optiflux® Ultra | 0500418E | FDA UDI | Class II | Unknown |
| Optiflux® Ultra | 0500419E | FDA UDI | Class II | Unknown |
| stay.safe® | 050-95001 | FDA UDI | Class II | Active |
| Optiflux® | 0500320A | FDA UDI | Class II | Unknown |
| stay.safe® | 050-50758 | FDA UDI | Class II | Active |
| stay.safe® | 050-95004 | FDA UDI | Class II | Active |
| stay.safe® | 050-95003 | FDA UDI | Class II | Active |
| stay•safe® Handi-tool | 030-10810-1 | FDA UDI | Class II | Active |
| Safe-Lock® | 050-75000 | FDA UDI | Class II | Active |
| Optiflux® Ultra | 0500416E | FDA UDI | Class II | Unknown |
| CombiSet | 03-2722-9 | FDA UDI | Class II | Active |
| CombiSet | 03-2622-3 | FDA UDI | Class II | Active |
| CombiSet | 03-2630-6 | FDA UDI | Class II | Active |
| 2008T BlueStar Hemodialysis Machine | 191130 | FDA UDI | Class II | Active |
| FX CorAL 800 Dialyzer | F00009221 | FDA UDI | Class II | Active |
| Optiflux® | 0500318E | FDA UDI | Class II | Active |
| Optiflux® | 0500320N | FDA UDI | Class II | Unknown |
| stay.safe® | 050-95005 | FDA UDI | Class II | Active |
| Liberty® PDx | 050-87221 | FDA UDI | Class II | Active |
| Fresenius | 04-9006-5 | FDA UDI | Class II | Active |
| Optiflux® | 0500318N | FDA UDI | Class II | Active |
| CombiSet | 03-2692-6 | FDA UDI | Class II | Active |
| MeDS Pump | 04-7103-7 | FDA UDI | Class II | Unknown |
| VersiPD | 050-87224 | FDA UDI | Class II | Active |
| VersiPD | 030-40000 | FDA UDI | Class II | Active |
| NaturaLyte | 08-4000-LB 6.4L | FDA UDI | Class II | Active |
| Crit-Line® | CL10051001 | FDA UDI | Class II | Active |
| CombiSet | 03-2621-5 | FDA UDI | Class II | Active |
| FX CorAL 100 Dialyzer | F00009218 | FDA UDI | Class II | Active |
| Bibag | 08-4080-BB | FDA UDI | Class II | Active |
| Hemoflow™ | 0500164A | FDA UDI | Class II | Unknown |
| stay.safe® | 026-20030 | FDA UDI | Class II | Active |
| Liberty® Select Cycler | 180343 | FDA UDI | Class II | Active |
| Liberty® | 050-87212 | FDA UDI | Class II | Active |
| VersiPD | 050-87225 | FDA UDI | Class II | Active |
| Optiflux® | 0500320E | FDA UDI | Class II | Active |
| Optiflux® | 0500325E | FDA UDI | Class II | Active |
| 2008T BlueStar Hemodialysis Machine | 191126 | FDA UDI | Class II | Active |
| stay.safe® | 050-95013 | FDA UDI | Class II | Active |
| Fresenius | 04-9502-8 | FDA UDI | Class II | Active |
| Hemoflow™ | 0500136A | FDA UDI | Class II | Unknown |
| CombiSet | 03-2795-7 | FDA UDI | Class II | Active |
| FX CorAL 120 Dialyzer | F00009219 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Fresenius Medical Care Holdings, Inc. has 160 recall records spanning from September 3, 2010, to May 12, 2026, with statuses including completed, open, classified, and terminated. The reasons cited involve technical discrepancies such as incorrect display values (e.g., Acetate readings on GranuFlo), exposure to improper cold temperatures for dialyzers, user interface malfunctions (e.g., disappearing cursors or incorrect timestamps), mechanical failures (e.g., dialyzate port leaks, loose blood pump components), and labeling updates (e.g., revised warnings, foreign material in container caps). Some recalls address system design improvements, such as pressure transducer replacements or concentrate flow pressure adjustments, while others involve operational or instructional corrections.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 12, 2026 | Z-2321-2026 | — | open, classified | 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. |
| Oct 25, 2025 | Z-0936-2026 | — | open, classified | 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. |
| Aug 29, 2025 | Z-0041-2026 | — | open, classified | 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. |
| Apr 29, 2025 | Z-1992-2025 | — | open, classified | 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. |
| Dec 5, 2024 | Z-0801-2025 | — | open, classified | Potential for internal blood leaks due to cracked polyurethane |
| Aug 8, 2024 | Z-3124-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2344-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2342-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2345-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2340-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2346-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2341-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2347-2024 | — | open, classified | 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. |
| Jun 3, 2024 | Z-2343-2024 | — | open, classified | 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. |
| May 16, 2024 | Z-2141-2024 | — | open, classified | 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. |
| Apr 17, 2024 | Z-1866-2024 | — | open, classified | 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. |
| Apr 17, 2024 | Z-1870-2024 | — | open, classified | 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. |
| Apr 17, 2024 | Z-1869-2024 | — | open, classified | 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. |
| Apr 17, 2024 | Z-1867-2024 | — | open, classified | 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. |
| Apr 17, 2024 | Z-1868-2024 | — | open, classified | 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. |
| Apr 8, 2024 | Z-1822-2024 | — | open, classified | 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. |
| Jan 23, 2024 | Z-1323-2024 | — | open, classified | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Z-1325-2024 | — | open, classified | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Z-1326-2024 | — | open, classified | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Z-1324-2024 | — | open, classified | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Z-1327-2024 | — | open, classified | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Oct 24, 2023 | Z-0619-2024 | — | open, classified | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. |
| Oct 10, 2023 | Z-0507-2024 | — | open, classified | Updating the labeling to include additional warnings and contraindications for potential side effects. |
| Sep 6, 2023 | Z-0035-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Z-0034-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Z-0029-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Z-0032-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Z-0028-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Z-0031-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Z-0033-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Sep 6, 2023 | Z-0030-2024 | — | open, classified | Potential PCBA leaching from tubing of hemodialysis machines. |
| Aug 8, 2023 | Z-0005-2024 | — | open, classified | There is a potential for blood backfill leakage and foreign material. |
| Aug 8, 2023 | Z-0007-2024 | — | open, classified | There is a potential for blood backfill leakage and foreign material. |
| Aug 8, 2023 | Z-0006-2024 | — | open, classified | There is a potential for blood backfill leakage and foreign material. |
| Oct 4, 2022 | Z-0181-2023 | — | open, classified | 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. |
| Jul 27, 2022 | Z-0734-2023 | — | open, classified | (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 alarm "Remove USB 2 Device". |
| Jun 21, 2022 | Z-1770-2022 | — | open, classified | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| Jun 21, 2022 | Z-1769-2022 | — | open, classified | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| Jun 16, 2022 | Z-1463-2022 | — | open, classified | 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 the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock |
| Jun 16, 2022 | Z-1464-2022 | — | open, classified | 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 the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock |
| Jun 1, 2022 | Z-1311-2022 | — | terminated | 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 infection. |
| May 31, 2022 | Z-1371-2022 | — | open, classified | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use |
| May 31, 2022 | Z-1370-2022 | — | open, classified | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use |
| May 4, 2022 | Z-1303-2022 | — | terminated | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure. |
| Dec 7, 2021 | Z-0562-2022 | — | open, classified | 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 communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection. |
| Aug 3, 2021 | Z-1364-2022 | — | terminated | 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. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation |
| Apr 28, 2021 | Z-2084-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2089-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2082-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2083-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2088-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2085-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2090-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2086-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Apr 28, 2021 | Z-2087-2021 | — | terminated | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Mar 18, 2021 | Z-1536-2021 | — | terminated | AquaBplus HF module on the AquaBplus 2500 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 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation |
| Dec 17, 2020 | Z-0942-2021 | — | terminated | Bottles Missing Product Label |
| Nov 23, 2020 | Z-0834-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0839-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0836-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0841-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0837-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0835-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0833-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0840-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0832-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0831-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 23, 2020 | Z-0838-2021 | — | open, classified | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Nov 7, 2020 | Z-0812-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0813-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0815-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0818-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0825-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0829-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0817-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0822-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0823-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0820-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0824-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0811-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0814-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0826-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0828-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0819-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0821-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0816-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Nov 7, 2020 | Z-0827-2021 | — | open, classified | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Sep 12, 2020 | Z-0439-2021 | — | completed | The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure. |
| Sep 1, 2020 | Z-0098-2021 | — | terminated | Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff. |
| Mar 12, 2020 | Z-1748-2020 | — | open, classified | A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine |
| Mar 12, 2020 | Z-1749-2020 | — | open, classified | A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine |
| Jan 29, 2020 | Z-1529-2020 | — | terminated | The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part. |
| Jul 16, 2015 | Z-2373-2015 | — | open, classified | Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. |
| May 20, 2015 | Z-1827-2015 | — | open, classified | Bacterial contamination. |
| Apr 27, 2015 | Z-1716-2015 | — | terminated | Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber |