Hazard

Therapy Interruption recalls

76 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 76
Critical: 5
Severe: 22
Most recent: 2026-05-27

Of the 76 therapy interruption recalls we have scored against our rubric, 5 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 22 (29%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all therapy interruption recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 76

SevereFDA (Devices)·Z-1271-2022·2022-06-29
Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures
Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.
Product
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1272-2022·2022-06-29
Medfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption
Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.
Product
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1151-2021·2021-03-10
Baxter Recalls PrisMax Hemodialysis Tubing Due to Performance Variability
Baxter Healthcare is recalling PrisMax System Version II hemodialysis tubing due to performance variability that may cause alarms and therapy interruptions.
Product
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump As
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2716-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8000 Recall for Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.
Product
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2722-2020·2020-08-12
CareFusion Alaris SpO2 Modules Recalled for Cleaning-Related Connector Damage
CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring interruptions.
Product
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2721-2020·2020-08-12
CareFusion Alaris EtCO2 Module Recall Due to Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.
Product
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2741-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall
CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
Product
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Category
Medical Device
Distribution
55 states
HighFDA (Devices)·Z-2723-2020·2020-08-12
CareFusion Alaris Auto ID Module Recall Due to Cleaning Agent Damage
CareFusion is recalling Alaris Auto ID Modules because cleaning agents may damage connectors, causing infusion interruptions and therapy stops.
Product
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2020·2020-08-12
CareFusion Alaris Pump Module 8100 Recalled for Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because cleaning agents may damage connectors, causing therapy interruptions.
Product
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2717-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 infusion pumps because cleaning agents may damage connectors, potentially interrupting therapy or monitoring.
Product
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2720-2020·2020-08-12
CareFusion Alaris PCA Module 8120 Recalled for Cleaning Agent Damage
CareFusion 303, Inc. is recalling 83,532 Alaris PCA Module Model 8120 units because cleaning agents may damage connectors, causing therapy interruptions.
Product
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2740-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8000 Infusion Pump Recall
CareFusion is recalling Alaris System PC Unit Model 8000 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
Product
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Category
Medical Device
Distribution
55 states
HighFDA (Devices)·Z-2719-2020·2020-08-12
CareFusion Alaris Syringe Module Recall Due to Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.
Product
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2542-2020·2020-07-15
KCI ACTIV.A.C Therapy System Recalled for Unexpected Power Off
KCI USA is recalling ACTIV.A.C Therapy Systems because they may power off without warning, stopping negative pressure wound therapy.
Product
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0610-2020·2019-12-18
Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall
Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.
Product
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0277-2020·2019-11-13
Baxter Prismaflex Control Unit Recalled for Potential Therapy Interruption
Baxter Healthcare is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Product
Prismaflex Control Unit, software versions below 7.21
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0279-2020·2019-11-13
Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk
Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Product
Prismaflex Control Unit, software versions below 7.21
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0276-2020·2019-11-13
Baxter Prismaflex Control Unit Recalled for Communication Error Alarms
Baxter Healthcare is recalling Prismaflex Control Units with software versions below 7.21 because communication error alarms may interrupt therapy or cause blood loss.
Product
Prismaflex Control Unit, software versions below 7.21
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0278-2020·2019-11-13
Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk
Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Product
Prismaflex Control Unit, software versions below 7.21
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0280-2020·2019-11-13
Baxter Prismaflex Control Unit Recalled for Communication Error Alarms
Baxter Healthcare is recalling 336 Prismaflex Control Units with software versions below 7.21 due to communication error alarms that may interrupt therapy or cause blood loss.
Product
Prismaflex Control Unit, software versions below 7.21
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0100-2019·2018-11-07
Maquet Cardiosave Rescue IABP Recalled for High Altitude Therapy Interruption
Maquet Datascope is recalling Cardiosave Rescue IABP devices due to a potential inability to start therapy at altitudes above 3,200 feet.
Product
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3086-2017·2017-09-13
Maquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects
Maquet Datascope is recalling 14,547 CS 100 Intra-Aortic Balloon Pumps worldwide due to a defect that could prevent therapy initiation or continuation.
Product
CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3085-2017·2017-09-13
Maquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress
Maquet Datascope is recalling 14,547 CS 100i Intra-Aortic Balloon Pumps because fluid ingress and false alarms could prevent therapy.
Product
CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3087-2017·2017-09-13
Maquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk
Maquet Datascope is recalling CS 300 Intra-Aortic Balloon Pumps because fluid ingress could damage electronic boards, potentially preventing therapy initiation or continuation.
Product
CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3031-2017·2017-08-23
ICU Medical Recalls Plum 360 Infusion Systems Due to Module Disengagement Risk
ICU Medical is recalling 68,559 Plum 360 Infusion Systems because the Connectivity Engine Module may disengage, causing the unit to shut down without an alarm and interrupting therapy.
Product
Plum 360 Infusion System
Category
Medical Device
Distribution
Distributed nationwide