95,018 total recalls in our database
Philips Respironics
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.
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.
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.
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.
No 510(k) clearance
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.
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.
Owen Mumford USA
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.
Mercedes Medical
No 510(k) clearance
GE Healthcare
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.
Unknown Manufacturer
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.
Unknown Manufacturer
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.
Unknown Manufacturer
The fan's lithium ion battery can overheat while charging, posing a fire hazard.
Unknown Manufacturer
Wood stored under the unit can ignite, posing a fire hazard.
FO-ND, LLC. (dba Firebird Artisan Mills)
Organic Brown Rice Flour has the potential to be contaminated with Salmonella.
Firm testing found trace levels of yeast in the product. Further investigation found the presence of Candida pelliculosa.
Product may contain elevated levels of inorganic arsenic (above 100ppb)
Heritage Family Specialty Foods
Potential to contain a foreign material
Heritage Family Specialty Foods
Potential to contain a foreign material
Greenwood Ice Cream
During an FDA inspection the firm was notified that their ingredient statement does not include soy. Undeclared soy in ice cream