Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class I · 5 months ago
Becton Dickinson & Company BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 recall: This is a sub-recall of a product recall from Huons Co, Ltd
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is…
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Class II · 5 months ago
CareFusion 303, Inc. BD Pyxis Mini Main REF: 349 Medication cabinet recall: Fingerprint scanner may overheat to a temperature to cause 1st degree burn
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
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Class II · 5 months ago
Intuitive Surgical, Inc. Brand Name: Da Vinci 5 Product Name: Assy,DV5 Tower recall: Due to unintentionally activated near infrared handheld camera
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions…
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Class II · 5 months ago
Philips Azurion 3M12, Model Numbers: 722063 recall: During the device phase of Roadmap Pro, a user may experience a dark image
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user…
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Class II · 5 months ago
Bayer Medical Care, Inc. Avanta Multi-Patient Administration Tube Sets ) used recall: Supplier changes resulted in a fit issue with the Contrast Flow Control Valve
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer…
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Class II · 5 months ago
CareFusion 303, Inc. BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet recall: Fingerprint scanner may overheat to a temperature to cause 1st degree burn
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
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Class I · 5 months ago
Becton Dickinson & Company BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 recall: This is a sub-recall of a product recall from Huons Co, Ltd
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is…
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Class II · 5 months ago
B Braun Medical Inc Brand Name: B. Braun Medical INC Product Name: Cesk Northside recall: B. Braun was notified by our supplier, Ferndale Laboratories, Inc
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary…
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Class I · 5 months ago
Draeger, Inc. Atlan A350XL recall: The Atlan anesthesia workstation either indicated a failure of the piston
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation…
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Class II · 5 months ago
Covidien Mon-a-Therm general purpose recall: Temperature probe devices lack FDA clearance
Temperature probe devices lack FDA clearance.
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Class I · 5 months ago
B Braun Medical Inc Spinocan Spinal Needle procedure kits: Material Description recall: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a…
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Class I · 5 months ago
Becton Dickinson & Company BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 recall: This is a sub-recall of a product recall from Huons Co, Ltd
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is…
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Class II · 5 months ago
Philips Azurion 3M15, Model Numbers: 722064 recall: During the device phase of Roadmap Pro, a user may experience a dark image
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user…
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Class II · 5 months ago
B Braun Medical Inc Brand Name: B. Braun Medical INC. Product Name: Cesk Harris recall: B. Braun was notified by our supplier, Ferndale Laboratories, Inc
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary…
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Class II · 5 months ago
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002 recall: A limited number of Pocket Adaptor Kits, Model 64001 and 64002
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
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Class II · 5 months ago
GE Medical Systems Information Technologies Inc GE HealthCare Carescape Telemetry recall: GE HealthCare has become aware of an unlikely situation where potential loss
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server…
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Class II · 5 months ago
GE Medical Systems Information Technologies Inc GE HealthCare Apexpro v5.0 - ARK2250 recall: GE HealthCare has become aware of an unlikely situation where potential loss
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server…
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Class II · 5 months ago
GE Medical Systems Information Technologies Inc GE HealthCare IOU Assy ARK2250 recall: GE HealthCare has become aware of an unlikely situation where potential loss
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server…
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Class I · 5 months ago
Abiomed, Inc. Automated Impella Controller recall: A retrospective review identified that there are AIC units requiring specific
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware…
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Class II · 5 months ago
Devicor Medical Products Inc HydroMARK Breast Biopsy Site Marker recall: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
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Class II · 5 months ago
Philips Medical Systems Nederland B.v. Allura system recall: It was identified that HDDs used in the PCs of Azurion and Allura systems
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six…
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Class II · 5 months ago
GE Medical Systems Information Technologies Inc GE HealthCare Carescape Telemetry recall: GE HealthCare has become aware of an unlikely situation where potential loss
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server…
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Class II · 5 months ago
O&m Halyard Inc Halyard Purezero Ultraviolet recall: Nitrile Exam Glove failed to meet specifications chemical permeation
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
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Class II · 5 months ago
Philips Medical Systems Nederland B.v. Azurion system recall: It was identified that HDDs used in the PCs of Azurion and Allura systems
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six…