Medical DeviceApr 24, 2024
Philips Ingenia Elition X, Magnetic Resonance System recall — FDA Z-1571-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
April 2024 recalls — page 3
These records include useful source details for the selected month.
Medical DeviceApr 24, 2024
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only recall — FDA Z-1536-2024
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class IIFDA: OngoingMasimo Corporation
Medical DeviceApr 24, 2024
Cook Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring recall — FDA Z-1529-2024
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIFDA: OngoingCook Inc.
Medical DeviceApr 24, 2024
Conformis Identity Imprint PS Tibial Tray Size 4: Lot 540287 recall — FDA Z-1591-2024
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Class IIFDA: OngoingConformis, Inc.
Medical DeviceApr 24, 2024
Philips Respironics Aeris EVO, all software versions except 1.05.06.00 recall — FDA Z-1499-2024
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceApr 24, 2024
Philips Respironics LifeVentEVO2, all software versions except 1.05.06.00 recall — FDA Z-1501-2024
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceApr 24, 2024
Cook Dilator - Intended to be used for dilating puncture sites or catheter tracts for recall — FDA Z-1530-2024
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIFDA: OngoingCook Inc.
Medical DeviceApr 24, 2024
Baxter Healthcare Surgical Tools and Cardiovascular Specialty marketing brochures, Reference recall — FDA Z-1524-2024
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceApr 24, 2024
SonarMed AW-S030 NEO SONARMED SENSOR 3.0MM recall — FDA Z-1520-2024
The failure to detect the partial obstruction in a 2.5mm sensor.
Class IFDA: OngoingSonarMed Inc.
Medical DeviceApr 24, 2024
Philips Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System recall — FDA Z-1579-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Cook Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode recall — FDA Z-1528-2024
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIFDA: OngoingCook Inc.
Medical DeviceApr 24, 2024
Randox Laboratories Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the recall — FDA Z-1594-2024
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceApr 24, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only recall — FDA Z-1539-2024
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class IIFDA: OngoingMasimo Corporation
Medical DeviceApr 24, 2024
Randox Laboratories Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the recall — FDA Z-1593-2024
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceApr 24, 2024
Siemens Healthcare Diagnostics Atellica CH Iron3 - IVD use in the quantitative measurement recall — FDA Z-1549-2024
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 24, 2024
Philips Ingenia Elition S, Magnetic Resonance System recall — FDA Z-1570-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Baxter Healthcare Surgical Tools and Cardiovascular Specialty marketing brochures, Reference recall — FDA Z-1523-2024
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceApr 24, 2024
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 recall — FDA Z-1543-2024
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect…
Class IIFDA: OngoingSmiths Medical ASD Inc.
Medical DeviceApr 24, 2024
Baxter Healthcare Surgical Tools and Cardiovascular Specialty marketing brochures, Reference recall — FDA Z-1522-2024
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceApr 24, 2024
Philips Ingenia 1.5T CX, Magnetic Resonance System recall — FDA Z-1564-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System recall — FDA Z-1578-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Achieva XR, Magnetic Resonance System recall — FDA Z-1556-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) recall — FDA Z-1541-2024
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect…
Class IIFDA: OngoingSmiths Medical ASD Inc.
Medical DeviceApr 24, 2024
Philips GYROSCAN ACS-NT, Magnetic Resonance System recall — FDA Z-1559-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.