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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Mar 26, 2015 Other Medical Devices Nationwide View Details →

1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Mar 26, 2015 Other Medical Devices Nationwide View Details →

113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

ICU Medical

Class I - Dangerous

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Apr 20, 2015 Infusion Pumps Nationwide View Details →

BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.

Bard Peripheral Vascular

Class I - Dangerous

The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.

Apr 9, 2015 Surgical Instruments Nationwide View Details →

ViewRay System, Radiation Therapy System

Viewray Incorporated

Class I - Dangerous

The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.

Jan 15, 2015 Other Medical Devices View Details →

3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Mar 26, 2015 Other Medical Devices Nationwide View Details →

3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Mar 26, 2015 Other Medical Devices Nationwide View Details →

1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Mar 26, 2015 Other Medical Devices Nationwide View Details →

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

Spacelabs Healthcare

Class I - Dangerous

Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.

Apr 21, 2015 Diagnostic Equipment Nationwide View Details →

Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.

Stryker Instruments Div. of Stryker

Class I - Dangerous

The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.

Mar 25, 2015 Surgical Instruments Nationwide View Details →

CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray

B. Braun Medical

Class I - Dangerous

There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space.

Mar 27, 2015 Other Medical Devices Nationwide View Details →

104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

ICU Medical

Class I - Dangerous

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Apr 20, 2015 Infusion Pumps Nationwide View Details →