Hazard

Inaccurate Monitoring recalls

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

What the numbers show

Total: 22
Critical: 0
Severe: 9
Most recent: 2025-03-05

Of the 22 inaccurate monitoring recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (41%) 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 inaccurate monitoring 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.

1–22 of 22

SevereFDA (Devices)·Z-1196-2025·2025-03-05
Ventec VOCSN Ventilators Recalled Due to Incorrect Service Parts
Ventec Life Systems recalled VOCSN Multi-Function Ventilators (30 units in CA, NY, MO) due to incorrect parts used during service. Defects may cause unexpected shutdown or impaired respiratory monitoring and support.
Product
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0197-2025·2024-10-30
Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits
Smiths Medical ASD, Inc. is recalling 800 units of medex TranStar KIDS KIT closed blood sample kits due to a manufacturing defect that may cause inaccurate pressure monitoring.
Product
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0184-2025·2024-10-30
Smiths Medical Recalls 50 medex NICU Monitoring Kits Due to Defect
Smiths Medical ASD, Inc. is recalling 50 medex NICU Monitoring Kits due to a manufacturing defect that may cause inaccurate pressure monitoring.
Product
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0202-2025·2024-10-30
medex TranStar Pressure Transducer Stopcock Recalled for Manufacturing Defect
Smiths Medical is recalling the medex TranStar Stopcock due to a manufacturing defect that can cause inaccurate pressure monitoring, interrupted pressure monitoring, or inability to zero the device.
Product
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0198-2025·2024-10-30
Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits
Smiths Medical ASD, Inc. is recalling 900 units of medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT due to a manufacturing defect that may cause inaccurate pressure monitoring.
Product
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0188-2025·2024-10-30
Smiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects
Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.
Product
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2883-2020·2020-09-02
GE Healthcare Recalls CARESCAPE R860 Ventilators Due to Oxygen Sensor Issue
GE Healthcare is recalling 2,277 CARESCAPE R860 ventilators because a potential oxygen sensor issue may cause inaccurate FiO2 readings.
Product
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2699-2020·2020-08-05
Resource Optimization Recalls Regard Migrating Indicator Strips for Malfunction
Resource Optimization & Innovation LLC is recalling Regard Migrating Indicator Strips because they malfunction and fail to reach the accept window during use.
Product
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1159-2020·2020-02-19
Pacific Medical Group Recalls Button-Style Tocotransducers Due to Unverified Components
Pacific Medical Group is recalling 9,679 Button-Style Tocotransducers serviced with non-OEM components that were not appropriately verified, posing risks of inaccurate monitoring and burns.
Product
Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1168-2020·2020-02-19
Pacific Medical Toco MP Transducers Recalled for Non-OEM Components
Pacific Medical Group Inc. is recalling Toco MP Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal monitoring and patient burns.
Product
Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1164-2020·2020-02-19
Pacific Medical Ultrasound Transducers Recalled for Unverified Service Components
Pacific Medical Group is recalling 1,994 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate fetal and maternal monitoring.
Product
Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1166-2020·2020-02-19
Pacific Medical Toco+ Transducers Recalled for Unverified Service Components
Pacific Medical Group is recalling 2,170 Toco+ transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal/maternal monitoring and patient burns.
Product
Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1161-2020·2020-02-19
Pacific Medical Group Recalls Ultrasound Transducers Serviced with Non-OEM Parts
Pacific Medical Group is recalling 6,481 Button-Style Ultrasound Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal and maternal monitoring or patient burns.
Product
Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Cor
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1167-2020·2020-02-19
Pacific Medical Ultrasound Transducers Recalled for Non-OEM Component Use
Pacific Medical Group is recalling 5,897 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate monitoring or patient burns.
Product
Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1160-2020·2020-02-19
Pacific Medical Loop-Style Tocotransducers Recalled for Unverified Service Components
Pacific Medical Group is recalling Loop-Style Tocotransducers serviced with unverified non-OEM components, which may cause inaccurate fetal monitoring or patient burns.
Product
Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assem
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1162-2020·2020-02-19
Pacific Medical Group Recalls Ultrasound Transducers Serviced with Non-OEM Parts
Pacific Medical Group is recalling Loop-Style Ultrasound Transducers serviced with unverified non-OEM components. The parts may cause inaccurate fetal monitoring and patient burns.
Product
Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corom
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2153-2019·2019-08-14
SenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency
SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.
Product
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2156-2019·2019-08-14
SenTec Membrane Changer Insert Recalled for Electrolyte Application Defect
SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced electrolyte application during sensor changes.
Product
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for car
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2152-2019·2019-08-14
SenTec Membrane Changer Recall Due to Electrolyte Application Defect
SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.
Product
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3192-2018·2018-09-26
Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error
Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.
Product
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2255-2015·2015-08-05
Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects
Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.
Product
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0822-2013·2013-02-20
Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings
Viterion TeleHealth Monitors are being recalled because they do not transmit 'HI' or 'LO' blood glucose readings from specific Bayer and Roche meters to healthcare professionals.
Product
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Category
Medical Device
Distribution
Distributed nationwide