Ivenix infusion pump cassette loading levers may break
The Large Volume Pump of the Ivenix Infusion System is being recalled because of the potential for the Cassette Loading Lever to break. 18,444 installed bases are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a component that loads the infusion cassette may break, a risk of harm with no injuries reported in the source.
Plain-English summary
The Large Volume Pump (LVP) of the Ivenix Infusion System, model number LVP-0004, UDI-DI 00811505030320, is being recalled. The action covers 18,444 installed bases.
The stated reason is the potential for the Cassette Loading Lever to break. The lever is used to seat the infusion cassette in the pump. The FDA classified the action as Class II.
Distribution was nationwide in the United States, including California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland and Maine. The pumps are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the model number and UDI-DI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion pump
- Affected units
- 18,444
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: LVP-0004. UDI-DI: 00811505030320
Distribution
Related recalls
Same manufacturer · Fresenius Kabi USA, LLC
See all →- SevereFresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- HighNaropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Same hazard · component breakage
See all →- HighFord and Lincoln windshield wiper arms may break causing wiper failure
NHTSA · 2026-03-31
- HighDual lumen stomach tubes recalled after anti-reflux valve breakage complaints
FDA (Devices) · 2025-10-29
- HighENFit sump tubes recalled after anti-reflux valve breakage complaints
FDA (Devices) · 2025-10-29
- HighGastric sump anti-reflux valves recalled after breakage complaints from excessive force
FDA (Devices) · 2025-10-29
- HighSilicone stomach tubes recalled after anti-reflux valve breakage complaints
FDA (Devices) · 2025-10-29
Similar recalls
- SevereLarge Volume Pump model LVP-0004 recalled for potential pneumatic valve failure
FDA (Devices) · 2025-01-15
- SevereIvenix Large Volume Infusion Pump Recalled Due to Fluid Ingress Risk
FDA (Devices) · 2023-04-19
- SevereIvenix infusion pumps may hide internal damage after being dropped
FDA (Devices) · 2026-06-10
- SevereInfusion pump recalled for mechanical valve interference interrupting therapy delivery
FDA (Devices) · 2023-12-27
- SevereIvenix pump software may report false battery health and shut down
FDA (Devices) · 2026-06-10
- ModerateInfusion pumps recalled over downstream occlusion alarms at low flow rates
FDA (Devices) · 2025-12-10