Medical Devices Recalls

Potential for microbial contamination of the product.

Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades.

Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

There is a possibility the handle of the laryngoscope may heat up and melt the end cap.

"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.

The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.

RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.

Laser aperture label was not affixed to device prior to shipment in the US.

Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.

Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.

Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.

Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affec

When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications