Hazard

False Alarm recalls

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

What the numbers show

Total: 82
Critical: 2
Severe: 12
Most recent: 2025-09-03

Of the 82 false alarm recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (15%) 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 false alarm 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 82

HighFDA (Devices)·Z-2960-2020·2020-09-23
Terumo Ultrasonic Air Sensor Recall Due to Backwards Crimped Wire
Terumo is recalling three Ultrasonic Air Sensors because a crimped wire was installed backwards, potentially causing false air bubble alarms during extracorporeal procedures.
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2961-2020·2020-09-23
Terumo Ultrasonic Air Sensor Recalled for Intermittent Connection Defect
Terumo is recalling two Ultrasonic Air Sensors because a manufacturing defect may cause intermittent connections and false air bubble alarms during extracorporeal procedures.
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2959-2020·2020-09-23
Terumo Ultrasonic Air Sensor Recall Due to Intermittent Connection
Terumo is recalling 100 Ultrasonic Air Sensors because a manufacturing defect may cause false air bubble alarms during extracorporeal procedures.
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2805-2020·2020-08-26
PVA PREVENT Emergency Ventilator Recalled for Potential Incomplete Air Delivery
Precision Valve & Automation is recalling three PVA PREVENT emergency ventilators due to a software error that may cause false alarms or incomplete air delivery cycles.
Product
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fati
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2424-2020·2020-07-01
GE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms
GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.
Product
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-0
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1748-2020·2020-04-29
Fresenius 2008T Hemodialysis Machines Recalled for False USB Alarm
Fresenius Medical Care is recalling 2008T hemodialysis machines because they may display a false 'Remove USB Device 2' alarm when no USB device is connected.
Product
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1749-2020·2020-04-29
Fresenius 2008T BlueStar Hemodialysis Machines Recalled for USB False Alarm
Fresenius Medical Care is recalling 15,342 hemodialysis machines because a false alarm may appear when a USB device is connected.
Product
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0313-2018·2018-01-10
Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Mechanism Defect
Smiths Medical ASD Inc. is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Product
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0314-2018·2018-01-10
Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening
Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Product
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2017·2017-01-25
CareFusion Recalls Alaris Pump Modules Due to False Air-in-Line Alarms
CareFusion is recalling Alaris Pump Modules and AIL sensor kits because false Air-in-Line alarms can interrupt medication infusions.
Product
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuou
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2016·2016-07-06
Hospira Symbiq Infusion Pumps Recalled for False Occlusion Alarms
Hospira is recalling Symbiq Two Channel Infusers due to frequent false occlusion alarms that may delay or interrupt patient therapy.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2055-2016·2016-07-06
Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms
Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal occlusion alarms that may delay or interrupt patient therapy.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1833-2016·2016-06-15
Hospira Recalls 2,567 Plum A+ Infusion Pumps Due to Calibration Error
Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.
Product
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1832-2016·2016-06-15
Hospira Recalls 1,490 Plum 360 Infusion Pumps Due to Calibration Error
Hospira is recalling 1,490 Plum 360 infusion pumps because a calibration error may cause false proximal occlusion alarms.
Product
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more r
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1325-2016·2016-04-13
Fresenius 2008 Series Hemodialysis Machines Recalled for False Blood Leak Alarms
Fresenius Medical Care is recalling 2008 Series hemodialysis machines because they may trigger false blood leak alarms when treating patients with Vitamin B-12.
Product
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0359-2016·2015-12-09
ConMed Recalls Altrus Thermal Tissue Fusion Energy Sources
ConMed is recalling nine Altrus Thermal Tissue Fusion Energy Sources due to a miscalibration issue that may cause false alarms and stop heating cycles.
Product
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1223-2015·2015-03-11
Ikaria INOmax DSIR Nitric Oxide Delivery System Recalled for Alarm Defect
INO Therapeutics is recalling 45 INOmax DSIR units because a specific software and display combination may trigger false alarms, interrupting nitric oxide therapy.
Product
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1705-2014·2014-06-11
Spacelabs Ultraview SL Command Module Recalled for Software Anomaly
Spacelabs Healthcare is recalling 64 Ultraview SL Command Modules because a software anomaly causes false positive temperature alarms.
Product
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1572-2014·2014-05-21
Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue
Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.
Product
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1549-2014·2014-05-14
GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Software Defect
GE Healthcare is recalling 21 Panda Freestanding Infant Warmers worldwide because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.
Product
Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1548-2014·2014-05-14
GE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect
GE Healthcare is recalling 723 Panda iRes Infant Warmers because defective software may cause false oxygen saturation and pulse rate alarms.
Product
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arteri
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1550-2014·2014-05-14
GE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect
GE Healthcare is recalling 15 Panda Wall-Mount Infant Warmers because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.
Product
Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1547-2014·2014-05-14
GE Healthcare Recalls Giraffe Infant Warmers Due to Alarm Defect
GE Healthcare is recalling 50 Giraffe Infant Warmers because a software defect may cause false oxygen saturation and pulse rate alarms.
Product
Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1528-2014·2014-05-14
INOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly
INO Therapeutics is recalling 22 INOmax DSIR Nitric Oxide Delivery Systems due to a software anomaly that may trigger unintended alarms.
Product
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The prim
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1551-2014·2014-05-14
GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect
GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.
Product
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology wi
Category
Medical Device
Distribution
0 states