There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Class I - Dangerous
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Class I - Dangerous
Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.
Class I - Dangerous
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
Class I - Dangerous
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Class I - Dangerous
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Class I - Dangerous
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.
System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
Stryker Instruments Div. of Stryker
Class I - Dangerous
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.
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
Arrow International
Class I - Dangerous
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.
Class I - Dangerous
Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).
Stryker Instruments Div. of Stryker
Class I - Dangerous
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.
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical
Class I - Dangerous
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.