Medical device recalls

A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument

Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

Reversed expiration and manufacturing date on the label

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

The seal integrity of the sterile bag containing the kits may be compromised.

Product Pouches may not be sealed properly and compromise the sterility of the device

Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.

Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

The injector holder could potentially fall off together with the injector and the storage box.

The injector holder could potentially fall off together with the injector and the storage box.

The injector holder could potentially fall off together with the injector and the storage box.