Every recall we track for Fresenius Kabi USA, LLC — 94 in all — plus the complaints and injury reports the public filed about them.
Fresenius Kabi recalls Tyenne (tocilizumab-aazg) injection due to glass particles found in some batches. This may cause serious injury if injected. Affected units have specific lot numbers and expiration dates.
Fresenius Kabi recalls Morphine Sulfate Injection syringes that may be labeled incorrectly with Dilaudid instead of Morphine. This could lead to incorrect medication use. Consumers should check labels and contact the company for details.
Fresenius Kabi recalls 25 single-dose vials of Lidocaine HCl Injection (2%) due to hair contamination. This may cause injury during injection. Contact the company for details.
Fresenius Kabi recalls Xylocaine 1% injection vials with hair particles found. Stop using affected vials immediately to avoid potential injury.
Fresenius Kabi recalls Naropin 0.5% injection vials due to hair particles found in some products. Affected lots may cause injury if injected. Contact for return instructions.
Fresenius Kabi recalls specific batches of Epinephrine Injection due to failed impurities and degradations. Affected units may pose health risks if used improperly. Contact for details.
Fresenius Kabi recalls Ivenix LVP-0004 infusion pumps that may malfunction after drops or jarring, causing random touchscreen inputs. Affected units have specific model and serial numbers.
Fresenius Kabi recalls Ivenix Infusion System software version 5.10.2 due to potential false battery alarms that may shut down the pump. Affected units have specific product codes and software versions.
Fresenius Kabi recalls 1,000mL 0.9% Sodium Chloride Injection due to lack of sterility assurance. This may cause infections if used improperly. Contact for return instructions.
Fresenius Kabi recalls specific batches of 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected products may cause infection if used. Check batch numbers and contact the company for details.
Fresenius Kabi recalls 50mL x60 packs of 0.9% Sodium Chloride Injection due to lack of sterility assurance. This could cause infections if used improperly. Affected batches expire by 10/31/2026 or 11/30/2026.
Fresenius Kabi recalls 50mL 0.9% Sodium Chloride Injection (Rx only) due to lack of sterility assurance. Products with specific batch numbers and expiration dates are affected. Consumers should contact the manufacturer for details.
Fresenius Kabi recalls 1000mL 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected batches expire through 2028. Consumers should contact the manufacturer for details.
Fresenius Kabi recalls 5% dextrose injection vials with potential lack of sterility. Affected units have specific NDC numbers and batch dates. Consumers should contact the company for details.
Fresenius Kabi recalls 5% Dextrose Injection (250 mL) due to lack of sterility assurance. This could cause infections if used improperly. Check your product details and contact the company for action.
Fresenius Kabi recalls 5% Dextrose Injection (50 mL) due to lack of sterility assurance. This could cause infections if used improperly. Contact the company for details.
Fresenius Kabi recalls certain 0.9% sodium chloride injection bags due to lack of sterility assurance. This could lead to infections if used improperly. Check batch numbers and contact the company for details.
Fresenius Kabi recalls 500mL 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected batches expire 09/30/2027 and 10/31/2027. Consumers should contact manufacturer for details.
Fresenius Kabi recalls 0.9% Sodium Chloride Injection (100mL) due to lack of sterility assurance. Affected batches expire by 01/31/2027 and 02/28/2027. No remedy specified in recall notice.
Fresenius Kabi recalls 500mL sodium chloride injection bags due to lack of sterility assurance. Affected units have specific batch numbers and expiration dates. Consumers should contact the manufacturer for details.
Fresenius Kabi recalls 0.45% Sodium Chloride Injection (250mL) with potential lack of sterility. This injectable solution is for prescription use only. Consumers should contact the manufacturer for details.
Fresenius Kabi recalls 0.9% Sodium Chloride Injection (250 mL) due to lack of sterility assurance. Affected batches have specific expiration dates and NDC numbers. Consumers should contact the manufacturer for details.
Fresenius Kabi recalls LVP-0004 infusion pumps due to potential cassette loading lever breakage. Affected units may require replacement to prevent injury.
Fresenius Kabi recalls Ivenix Infusion System software version 5.10.2 and prior due to potential LVP duration programming errors in instructions. Affected units may require software update to prevent infusion errors.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.10.1 and earlier due to potential patient harm or death risks. Affected units may require software update or replacement.
Fresenius Kabi recalls Famotidine injection vials due to microbial contamination and endotoxin testing issues. Affected lots have specific NDC numbers and expiration dates.
Fresenius Kabi recalls specific IVENIX infusion sets due to potential serious patient injury from incorrect assembly. Affected units include Lot FA25B03126. Contact for remedy details.
Fresenius Kabi recalls Ivenix Large Volume Pump (LVP-0004) due to potential downstream occlusion alarms during low flow infusions with check valves added to the administration set.
Fresenius Kabi recalls Ivenix Infusion System (LVP-0004) due to potential phantom touches on touchscreen. Affected units have specific serial numbers and model.
Fresenius Kabi recalls blood administration sets with potential for external cassette leaks. Affected units include specific product codes and lot numbers. Consumers should contact the company for details.
Fresenius Kabi recalls LVP Primary Administration Sets (Qty 25) due to potential external cassette leaks. Affected units have specific product codes and lot numbers.
Fresenius Kabi recalls 25 units of LVP Primary Administration Set with potential for external cassette leaks. Affected units have specific product codes and lot numbers. Contact for remedy details.
Fresenius Kabi recalls LVP Primary Administration Sets with potential for external cassette leaks. Affected units include specific product codes and lot numbers. Consumers should contact the manufacturer for details.
Fresenius Kabi recalls IVENIX infusion sets with a risk of blood clots if the 200-micron filter is incorrectly positioned. Affected units have model SET-0014-20 and UDI 20811505030034. Contact for return instructions.
Fresenius Kabi recalls Ivenix Infusion System software version 5.9.2 and earlier due to potential pump failure during alarms or infusion switching. Affected units sold in hospitals and outpatient care.
Fresenius Kabi recalls Ivenix Infusion System Large Volume Pump Model LVP-0004 due to potential pneumatic valve failure that may stop active infusions or prevent pump use. Affected units have specific serial numbers listed in the recall.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.9.1 and older due to potential alarms, pump failure, or unresponsive screens during therapy, risking serious harm or death.
Fresenius Kabi recalls LVP Primary Administration Sets with Product Code SET-0013-25 due to potential medication overdose risk. Affected units may cause dose errors during IV infusion.
Fresenius Kabi recalls Ivenix Infusion System software version 5.8.0 due to potential underdose, overdose, or delayed therapy causing serious harm or death.
Fresenius Kabi recalls Ivenix Infusion System Large Volume Pump LVP-0004 due to mechanical interference causing pump alarms and potential therapy delays or interruptions that could lead to serious harm or death.
Fresenius Kabi recalls Ivenix Infusion System software version 5.2.1/5.2.2 due to potential incorrect alarms that may delay therapy or cause over-infusion. Affected units were corrected in software version 5.8.0 by May-August 2023.
Recall of Fresenius Kabi Ivenix Infusion System Large Volume Pump Model LVP-0004 due to fluid ingress causing electrical failure and infusion halt. Affected units have specific serial numbers listed in the recall notice.
Fresenius Kabi recalls Sensorcaine injections with low epinephrine levels that may not work as intended. Affected batches expire 03/2024 or 05/2024. Stop using if you have these vials.
Fresenius Kabi recalls Sensorcaine-MPF injections with low epinephrine levels. This may cause ineffective anesthesia during procedures. Contact for details.
Fresenius Kabi recalls Sensorcaine injections with subpotent epinephrine due to testing below defined limits. Affected batches expire April 2024. Stop using immediately if you have the recalled product.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.0.1 and earlier due to potential incorrect alarms causing therapy delays or harm. Affected users should check their software version.
Fresenius Kabi recalls Ivenix Infusion System software version 5.2.0 due to potential screen freezing that can interrupt medication flow. Affected users should contact the company for updates.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.0.0 and 5.0.1 due to potential flow rate timing issues that could exceed 6 minutes in certain conditions. Affected units have specific software and part numbers.
Fresenius Kabi recalls Sodium Acetate Injection with particulate matter that could cause serious injury. Affected lots expire through 2023. Contact for return instructions.
Fresenius Kabi recalls Morphine Sulfate Injection vials with cracked containers that may cause contamination. Affected lots expire 03/2023 or 06/2023. Stop using and contact for replacement.
Fresenius Kabi recalls Xylocaine-MPF with Epinephrine 1:200,000 injection due to low epinephrine assay results. This may affect medical use safety. Check vial NDC 63323-487-07 or tray NDC 63323-487-37 for affected units.
