95,025 total recalls in our database
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Getinge Usa Sales
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
New Standard Device
Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
Alcon Laboratories Ireland
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
CardioTek BV
Device did not pass electrical safety testing for adequate insulation.
Getinge Usa Sales
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Unknown Manufacturer
One of the U-shaped buckles on the supporting cables can fail, posing an impact injury hazard to the user or bystander if the rack falls.
MTD Products Inc., of Cleveland, Ohio
The mower can leak fuel when it is stored in the upright (vertical) storage position, posing a fire hazard.
Unknown Manufacturer
The children's robes fail to meet the flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Unknown Manufacturer
The lithium-ion batteries in the umbrella's solar panels can overheat, posing fire and burn hazards.
Guangzhou Xiongyi Precision Metalworking Co. Ltd., of China
The glass Coda pendant light fixtures can detach from their electrical cord, causing the fixture to fall unexpectedly, posing a risk of injury from impact.
Unknown Manufacturer
The metal snaps on the rompers can detach, posing a choking hazard to young children.
Foreign object (metal).
The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
Deskins Wholesale
Products were made with peanut butter contaminated with Salmonella.
A G Specialty Foods
Potential contamination with Salmonella.
Foreign object (metal).