Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA,…
Lack of Assurance of Sterility
Read the official notice →- Date
- 2026-04-15
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC…
- Classification
- Class II
- Units
- US Nationwide , Alaska, and Puerto Rico.
- Category
- Drugs & medical
- Source
- FDA · Drug
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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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 Kabi recalls
- 2026-06-10
USFresenius Kabi USA, LLC recalls The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Potential for the Cassette Loading Lever to break.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD,…Official notice →- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore…
FDA · DeviceFresenius Kabi USA, LLCDomestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR,…Official notice → - US
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD,…Official notice → - 2026-01-21
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Emphasizing instructions for LVP duration programming located in the IFU.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI,…Official notice → - 2025-12-24
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
FDA · DeviceFresenius Kabi USA, LLCUS (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ,…Official notice → - 2025-12-10
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN,…Official notice →
Other drugs & medical recalls in the United States
- 2026-04-15
- US
- US
- US
Fagron Compounding Services recalls Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS…
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- US
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- 2026-04-08
- US
Cardinal Health 200, LLC recalls Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
GE Healthcare LLC recalls SIGNA Premier systems
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the…
FDA · DeviceGE Healthcare LLCWorldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH,…Official notice →