Surgical Instruments

Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.

Straight needle labeled as a curved needle

Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set and vice versa.

Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set and vice versa.

There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.

Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

The sterile battery may contain particulates within the sterile package.

Incorrect cannula of the sheath introducer (smaller than intended).

The sterile battery may contain particulates within the sterile package.

It was identified that in some situations the bed exit alarm may not function as intended. The software code for the bed exit system has the potential to auto-reset erroneously. In some situations, the software code does not allow enough time for the weight value to fall to zero once the patient egresses from the bed, in which case, the bed has the potential to reset the bed exit alarm even without a patient on the bed. The bed exit on the Spirit Select bed may incorrectly reset if the Auto Reset option is selected. A patient fall may result in soft tissue or bone injury which may require medical or surgical intervention to prevent permanent disability. If the bed exit alarm incorrectly resets then medical assistance after a fall or during entanglement may be delayed. Patients with dementia or disorientation are at greatest risk. There have been two reported injuries associated with these issues to date. A Medical Risk Assessment determined that there is a remote probability of occurrence of harm requiring medical intervention.

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.

Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.

Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. A component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. Other components within these kits are not affected.