All Recalls

95,114 total recalls in our database

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.

Tosoh Bioscience

🏥 Medical Devices Class I - Dangerous

Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.

Feb 23, 2012 Diagnostic Equipment Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35

Medtronic Vascular

🏥 Medical Devices Class I - Dangerous

Sterility may be compromised due to an unsealed pouch

Jan 15, 2021 Surgical Instruments Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

Draeger Medical

🏥 Medical Devices Class I - Dangerous

Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.

Jan 29, 2021 Patient Monitors Nationwide View Details →

SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

Sunstar Americas

🏥 Medical Devices Class I - Dangerous

The product may be contaminated with Burkholderia cepacia

Feb 18, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

🏥 Medical Devices Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

Brainlab AG

🏥 Medical Devices Class I - Dangerous

In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.

Mar 1, 2021 Other Medical Devices View Details →

System INFX-8000V

Canon Medical System, USA

🏥 Medical Devices Class I - Dangerous

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

Feb 5, 2021 Other Medical Devices Nationwide View Details →

Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.

Howmedica Osteonics

🏥 Medical Devices Class I - Dangerous

Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.

Feb 10, 2021 Implants & Prosthetics View Details →