🏥 Medical Devices Class I - Dangerous
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
🏥 Medical Devices Class I - Dangerous
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
Boston Scientific
🏥 Medical Devices Class I - Dangerous
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
🏥 Medical Devices Class I - Dangerous
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
🏥 Medical Devices Class I - Dangerous
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
Philips Respironics
🏥 Medical Devices Class I - Dangerous
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
🏥 Medical Devices Class I - Dangerous
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
🏥 Medical Devices Class I - Dangerous
No 510(k) clearance
🏥 Medical Devices Class I - Dangerous
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Owen Mumford USA
🏥 Medical Devices Class I - Dangerous
Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Mercedes Medical
🏥 Medical Devices Class I - Dangerous
No 510(k) clearance
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
GE Healthcare
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Caldwell E-Max® Pro BT Earmuffs with rechargeable lithium battery packs
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The soldering within the lithium-battery pack housing can allow the wiring to detach and cause the unit to overheat, posing fire and burn hazards.
One Stop Gardens 15,000 and 30,000 BTU Tank Top Propane Heaters
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
In windy weather, the flame can be directed to the rear of the unit, which can melt the "tip switch" safety shut off feature at the rear of the heater. This poses a risk that the heater will not turn off if it tips over and poses a burn hazard to consumers.
Rechargeable handheld fans
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The fan's lithium ion battery can overheat while charging, posing a fire hazard.