Drugs & medicalClass II

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.

Read the official notice →
Date
2025-06-25
Country
United States
Brand
Fresenius Medical Care Holdings
Product
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number:…
Classification
Class II
Units
US Nationwide distribution in the state of Massachusetts.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Fresenius Medical Care Holdings recalls

  1. 2025-12-24
  2. US
    Drugs & medicalClass II

    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.

    FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: LA, MA, MN;Official notice →
  3. 2025-10-15
  4. US
    Drugs & medicalClass II

    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…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution.Official notice →
  5. 2025-07-02
  6. US
  7. 2025-01-15
  8. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe

    Potential for internal blood leaks due to cracked polyurethane

    FDA · DeviceFresenius Medical Care Holdings, Inc.Nationwide Distribution.Official notice →
  9. 2024-09-18
  10. US
    Drugs & medicalClass II

    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…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide. Canada.Official notice →
  11. 2024-07-24
  12. US
    Drugs & medicalClass II

    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.

    FDA · DrugFresenius Medical Care Holdings, Inc.NationwideOfficial notice →
All 33 Fresenius Medical Care Holdings recalls →

Other drugs & medical recalls in the United States

  1. 2025-07-02
  2. US
  3. 2025-06-26
  4. US
    Drugs & medical

    Boyro Baby Walkers Recalled Due to Risk of Serious Injury or Death to Children from Fall Hazard; Violations of the Federal Standard for Infant Walkers and Lead Content…

    The recalled baby walkers violate the federal safety standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step as required, posing a risk of serious injury or…

    CPSCAbout 1,500Official notice →
  5. 2025-06-25
  6. US
    Drugs & medicalClass II

    Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and…

    Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

    FDA · DeviceDiagnostica Stago, Inc.The affected lot was distributed to customers in various US states in October…Official notice →
  7. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump

    Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager…

    FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA,…Official notice →
  8. US
    Drugs & medicalClass II

    BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694…

    Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

    FDA · DeviceBALT USA, LLCWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →
  9. US
    Drugs & medicalClass II

    Preat Corp recalls Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with…

    Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

    FDA · DevicePreat CorpU.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA,…Official notice →
See all drugs & medical recalls →