Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B...
Reason: 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 ear...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Z-1749-2026April 8, 2026Northridge, CA
Medtronic MiniMed, Inc.
Class IIOngoing
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Z-1742-2026April 8, 2026Northridge, CA
Medtronic MiniMed, Inc.
Class IIOngoing
MiniMed 620G Insulin Pump (MMT-1750)
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Z-1739-2026April 8, 2026Northridge, CA
Medtronic MiniMed, Inc.
Class IIOngoing
Paradigm Insulin Pump (MMT-712, MMT-715)
Reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is ...
Z-1748-2026April 8, 2026Northridge, CA
Tandem Diabetes Care, Inc.
Class IIOngoing
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, ...
Reason: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connecte...
Z-1636-2026April 1, 2026San Diego, CA
Baxter Healthcare Corporation
Class IIOngoing
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Reason: Pumps were released without full testing being performed, including occlusion alarm testing.
Z-1368-2026February 25, 2026Deerfield, IL
CareFusion 303, Inc.
Class IIOngoing
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent a...
Reason: Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This is...
Z-1217-2026February 4, 2026San Diego, CA
ICU Medical, Inc.
Class IIOngoing
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivere...
Reason: Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the d...
Z-1121-2026January 28, 2026Deerfield, IL
ICU Medical, Inc.
Class IIOngoing
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivere...
Z-1120-2026January 28, 2026Lake Forest, IL
ICU Medical, Inc.
Class IIOngoing
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivere...
Z-1119-2026January 28, 2026Lake Forest, IL
ICU Medical, Inc.
Class IIOngoing
Plum Duo Infusion System, List Number 40002-04-01
Reason: ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails,...
Z-1094-2026January 21, 2026Lake Forest, IL
ICU Medical, Inc.
Class IIOngoing
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Reason: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate meth...