95,094 total recalls in our database
Encore Medical
Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.
Siemens Medical Solutions USA
Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
DeVilbiss Healthcare
A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Eight (8) issues were identified which may affect the results generated by the system software version.
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Stryker Sustainability Solutions
Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.
Toshiba American Medical Systems
During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
Unknown Manufacturer
The heat wrap can overheat, posing a burn hazard.
Novel Laboratories, of Somerset, N.J.
The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by children.
Electrolux Home Products Inc., of Charlotte, N.C.
The thermal switch on the ovens can malfunction due to improper manufacturing, posing a fire hazard to consumers.
Inovonics, of Louisville, Colo.
The transmitters and receivers can fail to send or receive a signal for help in an emergency.
Unknown Manufacturer
The nightgowns fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Unknown Manufacturer
Tabs on the hooks attaching the rope cocking device to the crossbow string can bind as the device is pulled back, causing the hooks to break and the rope to recoil, posing a risk of injury, including laceration.