Fresenius Kabi USA Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA Z-0885-2026
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC…
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues…
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance…
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Recalled lots were manufactured with double the amount of preservative concentration.
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred…
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Contaminated with Salmonella
Clostridium botulinum (uneviscerated fish)
Browse recent months with enough recall history for useful comparison.