Medical Devices Recalls

Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, unexpected low results and results flagged with assay errors.

3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.

The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.

The software was failing to determine new patient locations if imaging is not enabled during treatment.

Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

Catheters may not meet antimicrobial specification

Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

Catheters may not meet antimicrobial specification

The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.