BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris ...
Reason: If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failu...
Z-0430-2026November 26, 2025San Diego, CA
Tandem Diabetes Care, Inc.
Class IOngoing
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism...
Reason: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue ...
Z-0427-2026November 12, 2025San Diego, CA
CareFusion 303, Inc.
Class IOngoing
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve S...
Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occl...
Z-0035-2026October 15, 2025San Diego, CA
Baxter Healthcare Corporation
Class IOngoing
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that ...
Z-2332-2025September 10, 2025Deerfield, IL
Baxter Healthcare Corporation
Class IOngoing
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that ...
Z-2334-2025September 10, 2025Deerfield, IL
Baxter Healthcare Corporation
Class IOngoing
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that ...
Reason: Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop i...
Z-2343-2025September 3, 2025San Diego, CA
Baxter Healthcare Corporation
Class IIOngoing
Spectrum IQ Infusion Pump, Product Code 3570009
Reason: Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease...
Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occl...
Z-2180-2025August 13, 2025San Diego, CA
CareFusion 303, Inc.
Class IOngoing
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occl...
Z-2179-2025August 13, 2025San Diego, CA
Baxter Healthcare Corporation
Class IOngoing
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Z-2096-2025July 23, 2025Deerfield, IL
Baxter Healthcare Corporation
Class IOngoing
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Z-2095-2025July 23, 2025Deerfield, IL
ICU Medical, Inc.
Class IIOngoing
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Reason: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in ...
Z-1990-2025June 25, 2025Lake Forest, IL
ICU Medical, Inc.
Class IIOngoing
ICU Medical Plum Solos, Item number 400011001; infusion pump
Reason: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in ...
Z-1991-2025June 25, 2025Lake Forest, IL
Smiths Medical ASD, Inc.
Class IOngoing
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/...
Reason: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Z-1681-2025May 14, 2025Minneapolis, MN
Smiths Medical ASD, Inc.
Class IOngoing
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA E...
Reason: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Z-1682-2025May 14, 2025Minneapolis, MN
Smiths Medical ASD, Inc.
Class IOngoing
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLI...
Reason: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lea...
Reason: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lea...
Z-1668-2025May 14, 2025Minneapolis, MN
Medtronic MiniMed, Inc.
Class IIOngoing
Paradigm REF: MMT-712 and MMT-715
Reason: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressur...
Z-1255-2025March 12, 2025Northridge, CA
CareFusion 303, Inc.
Class IIOngoing
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, p...
Reason: Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could resul...
Z-1231-2025March 5, 2025San Diego, CA
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Reason: Devices were identified as released after repair without full testing being performed, which includes flow testing.
Z-0775-2025January 8, 2025Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Reason: Devices were identified as released after repair without full testing being performed, which includes flow testing.
Z-0776-2025January 8, 2025Deerfield, IL
Smiths Medical ASD, Inc.
Class IIOngoing
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Reason: The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains p...
Z-0466-2025November 27, 2024Minneapolis, MN
Baxter Healthcare Corporation
Class IIOngoing
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason: The door on the Spectrum IQ Infusion pump may not be able to fully close.
Z-0348-2025November 20, 2024Deerfield, IL
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason: Potential for error and inability to interrogate pump due to data corruption in the pump memory.