Reviewed V1 category

Infusion pumps

Programmable pumps and related systems that deliver medicines, fluids, or nutrition over time.

FDA product codes and descriptions are normalized into this consumer-facing category. Raw regulator terminology remains source evidence rather than separate public category pages.

7 tracked devices · 41 recall records

Devices in this category

B. Braun Infusomat Space Infusion Pump

B. Braun Medical Inc. · Infusion pumps

No recall records found

Last checked Aug 17, 2026

Baxter SIGMA Spectrum Infusion System

Baxter Healthcare Corporation · Infusion pumps

Active recall record

Last checked Oct 8, 2026

BD Alaris Infusion System

Becton, Dickinson and Company · Infusion pumps

Active recall record

Last checked Oct 8, 2026

CURLIN 6000 Ambulatory Infusion Pump

Moog Inc. · Infusion pumps

No recall records found

Last checked Aug 17, 2026

ICU Medical Plum 360 Infusion System

ICU Medical, Inc. · Infusion pumps

Active recall record

Last checked Oct 8, 2026

Medfusion 4000 Syringe Infusion Pump

Smiths Medical ASD, Inc. · Infusion pumps

No recall records found

Last checked Aug 17, 2026

Sapphire Infusion Pump

Eitan Medical · Infusion pumps

No recall records found

Last checked Aug 17, 2026

Recent recall records

Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

FDA · FDA event 98872Posted Jun 5, 2026

Class I recallOngoing

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

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 · FDA event 98929Posted Jun 3, 2026

Class I recallOngoing

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 98945

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 remained in service. More specifically,…

FDA · FDA event 98945Posted May 29, 2026

Class II recallOngoing

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA event 98699

Potential for the Cassette Loading Lever to break.

FDA · FDA event 98699Posted May 29, 2026

Class II recallOngoing

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer recall — FDA event 98750

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of…

FDA · FDA event 98750Posted May 14, 2026

Class II recallOngoing

BD Alaris System with Guardrails Suite MX recall — FDA event 98250

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

FDA · FDA event 98250Posted Mar 26, 2026BD Alaris Infusion System

Manufacturers in this category

Manufacturers are listed because their devices appear in monitored sources. Listing does not imply endorsement or partnership.

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Reviewed V1 category

Infusion pumps

Programmable pumps and related systems that deliver medicines, fluids, or nutrition over time.

FDA product codes and descriptions are normalized into this consumer-facing category. Raw regulator terminology remains source evidence rather than separate public category pages.

7 tracked devices · 41 recall records

Devices in this category

B. Braun Infusomat Space Infusion Pump

B. Braun Medical Inc. · Infusion pumps

No recall records found

Last checked Aug 17, 2026

Baxter SIGMA Spectrum Infusion System

Baxter Healthcare Corporation · Infusion pumps

Active recall record

Last checked Oct 8, 2026

BD Alaris Infusion System

Becton, Dickinson and Company · Infusion pumps

Active recall record

Last checked Oct 8, 2026

CURLIN 6000 Ambulatory Infusion Pump

Moog Inc. · Infusion pumps

No recall records found

Last checked Aug 17, 2026

ICU Medical Plum 360 Infusion System

ICU Medical, Inc. · Infusion pumps

Active recall record

Last checked Oct 8, 2026

Medfusion 4000 Syringe Infusion Pump

Smiths Medical ASD, Inc. · Infusion pumps

No recall records found

Last checked Aug 17, 2026

Sapphire Infusion Pump

Eitan Medical · Infusion pumps

No recall records found

Last checked Aug 17, 2026

Recent recall records

Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Class I recallOngoing

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

FDA · FDA event 98929Posted Jun 3, 2026

Class I recallOngoing

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 98945

FDA · FDA event 98945Posted May 29, 2026

Class II recallOngoing

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA event 98699

Potential for the Cassette Loading Lever to break.

FDA · FDA event 98699Posted May 29, 2026

Class II recallOngoing

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer recall — FDA event 98750

FDA · FDA event 98750Posted May 14, 2026

Class II recallOngoing

BD Alaris System with Guardrails Suite MX recall — FDA event 98250

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

FDA · FDA event 98250Posted Mar 26, 2026BD Alaris Infusion System

Manufacturers in this category

Manufacturers are listed because their devices appear in monitored sources. Listing does not imply endorsement or partnership.