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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Airway Mobilescope MAF-TM

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229

Smith & Nephew

Class I - Dangerous

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

Jun 13, 2018 Implants & Prosthetics Nationwide View Details →

VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793

Ortho Clinical Diagnostics

Class I - Dangerous

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

Jul 12, 2018 Diagnostic Equipment Nationwide View Details →

GOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

Ortho Clinical Diagnostics

Class I - Dangerous

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

Jul 12, 2018 Diagnostic Equipment Nationwide View Details →

Bronchovideoscope BF-1T60

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →