Surgical Instruments

Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

Incorrect size printed on the Milex Pessary Kit packaging label

Reports of formation of char adherent to the proximal part of the distal tip electrodes

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.

Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker.

The product labeling does not specify the 5 year shelf life of the product.

Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.

Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.

Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.

The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.

CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.

Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.