Medical device recalls

The kits contain surgical gowns which were subject to a recall by the supplier.

The kits contain surgical gowns which were subject to a recall by the supplier.

The kits contain surgical gowns which were subject to a recall by the supplier.

The kits contain surgical gowns which were subject to a recall by the supplier.

The kits contain surgical gowns which were subject to a recall by the supplier.

The kits contain surgical gowns which were subject to a recall by the supplier.

The kits contain surgical gowns which were subject to a recall by the supplier.

The kits contain surgical gowns which were subject to a recall by the supplier.

The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.

Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

A software issue that may affect the analyzer's result accuracy.

There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.

There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.

Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

Damaged ESD bags used for storing components in Processor PCA Replacement Kits

The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resistance. This could result in cracked or broken lenses.

Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.

Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.

The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.

The incorrect label was placed on both the primary and secondary package.

Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain