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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

W L Gore & Associates

Class I - Dangerous

When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.

Sep 9, 2020 Implants & Prosthetics Nationwide View Details →

Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.

Boston Scientific

Class I - Dangerous

Incorrectly installed base.

Sep 22, 2020 Diagnostic Equipment Nationwide View Details →

Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.

Philips North America

Class I - Dangerous

The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.

Sep 14, 2020 Other Medical Devices Nationwide View Details →

The Quidel Triage BNP Calibrators

Medline Industries

Class I - Dangerous

Product compromised during shipment.

Oct 1, 2020 Other Medical Devices View Details →

Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118

Becton Dickinson & Company

Class I - Dangerous

Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.

Sep 14, 2020 Other Medical Devices View Details →

Instructions For Use document of the GPS Trackers.

Blue Ortho

Class I - Dangerous

Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.

Sep 10, 2020 Other Medical Devices View Details →

Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Exactech

Class I - Dangerous

The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

Sep 25, 2020 Other Medical Devices Nationwide View Details →

9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal

Pentax of America

Class I - Dangerous

There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.

Sep 22, 2020 Other Medical Devices Nationwide View Details →

Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.

Microbiologics

Class I - Dangerous

KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

Oct 8, 2020 Other Medical Devices View Details →

LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

THREAD COUNSEL INC

Class I - Dangerous

Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.

Sep 17, 2020 Surgical Instruments View Details →

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

W L Gore & Associates

Class I - Dangerous

Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible

Sep 9, 2020 Implants & Prosthetics Nationwide View Details →

Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

Siemens Medical Solutions USA

Class I - Dangerous

Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).

Sep 21, 2020 Diagnostic Equipment Nationwide View Details →

Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

Boston Scientific

Class I - Dangerous

RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

Sep 16, 2020 Surgical Instruments Nationwide View Details →

Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.

Microbiologics

Class I - Dangerous

QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

Oct 8, 2020 Other Medical Devices View Details →

APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17)241201(30)50(10)4496182. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein

ICU Medical

Class I - Dangerous

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.