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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10 (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10 (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10 (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10 (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10 (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10 (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10 (m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3003-R-39, QTY 10 (n) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF G-40-1102, QTY 10 Intended for use in coagulating tissue.

Olsen Medical

Class I - Dangerous

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

May 11, 2018 Surgical Instruments View Details →

nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

NordicNeuroLab AS

Class I - Dangerous

There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.

Dec 21, 2012 Diagnostic Equipment Nationwide View Details →

Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.

Ad-Tech Medical Instrument

Class I - Dangerous

There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.

Dec 20, 2017 Other Medical Devices Nationwide View Details →

HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Ethicon Endo-Surgery

Class I - Dangerous

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

May 3, 2018 Implants & Prosthetics Nationwide View Details →

MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Medline Industries

Class I - Dangerous

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Apr 24, 2018 Surgical Instruments Nationwide View Details →

Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 Designed to hold active electrodes.

Olsen Medical

Class I - Dangerous

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

May 11, 2018 Surgical Instruments View Details →