Recall and safety-notice records

Records aggregated from the official sources MedWatcher monitors. Each record links back to its source with the agency identifier and dates. Sample records are labeled.

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Recall and safety-notice records

Records aggregated from the official sources MedWatcher monitors. Each record links back to its source with the agency identifier and dates. Sample records are labeled.

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IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

FDA · FDA event 97941Posted Dec 3, 2025

Class II recallOngoing

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 97939

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Filters

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

FDA · FDA event 97941Posted Dec 3, 2025

Class II recallOngoing

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 97939

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Recall and safety-notice records

Recall and safety-notice records

Filters

Filters

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 97939

Filters

Filters

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, recall — FDA event 97941

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 97939

BD Alaris Infusion System recall — FDA event 97669

Tandem Mobi Insulin Pump recall — FDA event 97662

Klassic BiPolar Head recall — FDA event 97708

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, recall — FDA event 97765

Dexcom G6 Android app recall: unexpected app termination

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403