Class I - Dangerous
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
B. Braun Medical
Class I - Dangerous
B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
Class I - Dangerous
The hose could separate from the blanket.
Class I - Dangerous
The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r
Class I - Dangerous
Grasper jaw may break when force is applied to the jaw
Class I - Dangerous
Leak issues were discovered through accelerated age testing.
Class I - Dangerous
Ultrasound needles may be defective and leak at the needle hub.
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Blue Belt Technologies MN
Class I - Dangerous
Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.
Class I - Dangerous
Ultrasound needles may be defective and leak at the needle hub.
Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
Possible breach in sterile barrier for inner and outer bags of the product.
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
Teleflex Medical
Class I - Dangerous
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
Teleflex Medical
Class I - Dangerous
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Class I - Dangerous
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Class I - Dangerous
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Biorep Technologies
Class I - Dangerous
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Class I - Dangerous
The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.