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Medical device recalls

Medical device recalls from FDA, newest first.
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2 recalls

Bard Access Systems BD Needle Kit for Powered Driver

BD Needle Kit for Powered Driver may have difficulty removing the obturator, potentially delaying therapy and causing serious injury or death.

High risk, FDA, Device defect

Terex Utilities Power Over Fiber Base Module

The Power Over Fiber Base Module is not certified and is improperly labeled.

Moderate risk, FDA, Unapproved product

2 recalls

Stryker Hoffmann II Connecting Rod Micro

Stryker Hoffmann II Connecting Rod Micro may crack following cleaning and sterilization.

Moderate risk, FDA, Device defect

Instrumentation Laboratory GEM Premier 5000 and GEM Premier 7000 Blood Analyzers

GEM Premier 5000 and 7000 systems with BCR wands may assign results to wrong patient.

Moderate risk, FDA, Device defect

1 recall

ResMed Astral 100 and 150 Ventilators

The Resmed Astral ventilator system can fail due to electrolyte leakage, interrupting ventilation therapy.

High risk, FDA, Device defect

2 recalls

Philips CT Scanners

The CT scan may not trigger automatically after Bolus Tracking, causing inadequate diagnosis and potential rescan.

Moderate risk, FDA, Device defect

Medtronic EOPA Arterial Cannulas

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass.

Moderate risk, FDA, Device defect

2 recalls

Permobil M5 Corpus Power Wheelchair

The M5 Corpus Power Wheelchair may drive under restricted conditions due to missing drive inhibit logic.

Moderate risk, FDA, Software defect

Permobil M3 Corpus Power Wheelchair

The Permobil M3 Corpus Power Wheelchair lacks a speed restriction when the seat lift exceeds 50 mm, which may cause falls or tipping.

Moderate risk, FDA, Software defect

1 recall

MiniMed Go App

The MiniMed Go App may miss nighttime alerts, leading to missed insulin doses and increased hyperglycemia risk.

Moderate risk, FDA, Software defect

3 recalls

Medline Convenience Kits

Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.

High risk, FDA, Device defect

Boston Scientific TheraSphere 360 Y-90 Management Platform

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input.

Moderate risk, FDA, Software defect

Olympus High Flow Insufflation Unit - UHI-4

The Olympus High Flow Insufflation Unit can have its front panel display turn off unexpectedly, and air delivery ceases.

Moderate risk, FDA, Device defect

1 recall

Penumbra System RED 68 Reperfusion Catheter

The Penumbra System RED 68 Reperfusion Catheter may fracture due to manufacturing issues.

Moderate risk, FDA, Manufacturing problem

2 recalls

Boston Scientific FARADRIVE Steerable Sheath Clear

The FARADRIVE Steerable Sheath Clear can have valve damage that may cause air ingress and potential air embolism.

Moderate risk, FDA, Device defect

SeaSpine Polyaxial Head

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Moderate risk, FDA, Manufacturing problem

3 recalls

Ferno Power F2 Powered Fastening System

The Power F2 Powered Fastening System may experience accelerated roller wear and deformation, causing the rail to lodge and delaying patient transport.

Moderate risk, FDA, Device defect

Hotline Fluid Warming Set

The Hotline Fluid Warming Set may have an increased likelihood of leakage in specific lots.

Moderate risk, FDA, Device defect

Paragon 28 Phantom Hindfoot TTC/TC Ball Tipped Guide Rod

The P28 Phantom Intramedullary Nail System guide rod has breaches in its sterile barrier.

Moderate risk, FDA, Sterility problem

1 recall

Tosoh ST AIA-Pack Testosterone Test

The test cup lot F level 1 low-quality control results were lower than expected, which could cause falsely elevated or falsely low total testosterone results.

Moderate risk, FDA, Device defect

4 recalls

Daavlin Photera Phototherapy Devices

The Photera 400 phototherapy device has incorrect UV sensor gain.

Moderate risk, FDA, Device defect

Vasoview Hemopro 2 Endoscopic Vessel Harvesting System

The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System was exposed to an out-of-specification sterilization dose.

Moderate risk, FDA, Quality testing problem

Papablic Replacement Brush Heads

Papablic Replacement Brush Heads have a potential to break.

Moderate risk, FDA, Device defect

3B Medical Rio II Nasal Pillows Interface

The Rio" II Nasal Pillows Interface has a packaging and labeling discrepancy involving product size identification and associated UDI.

Moderate risk, FDA, Labeling error

1 recall

Orthofix Minirail External Fixation Devices

Unilateral external fixation devices may be incorrectly labeled.

Moderate risk, FDA, Labeling error

1 recall

GE Optima XR200amx, XR220amx and XR240amx Radiographic Systems

This could result in patient injury during an exam.

Moderate risk, FDA, Device defect

6 recalls

Boston Scientific Rapid Refill Continuous Injection System

The Rapid Refill Continuous Injection System contains a syringe that may loosen or disconnect, causing fluid leakage or separation.

Moderate risk, FDA, Device defect

ICU Medical Plum Duo Infusion and Solo Precision IV Pump

The Plum Duo Infusion Pump may deliver up to twice the programmed volume in a specific scenario.

Moderate risk, FDA, Device defect

Argon Medical Devices Cardiovascular and Biopsy Trays

Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F may not meet sterility release criteria.

High risk, FDA, Sterility problem

Abiomed Impella Heart Pumps and Introducer Kits

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.

High risk, FDA, Manufacturing problem

Olympus Evacuators

Some sterilization parameters may not consistently render the devices adequately sterile.

Moderate risk, FDA, Sterility problem

Intuitive Surgical da Vinci SP Instrument Arm Drape

The da Vinci SP Instrument Arm Drape may detach from the instrument arm, exposing a section and causing procedure delay or conversion.

Moderate risk, FDA, Device defect

3 recalls

OmniTract Surgical Retractor System

The OmniTract Surgical Retractor System has a dry time that needs to be extended.

Moderate risk, FDA, Sterility problem

GSP Neonatal GALT Kit

The GSP Neonatal GALT Kit may have a stability issue that can delay patient results.

Moderate risk, FDA, Device defect

Elekta Brachytherapy Applicators

The Fletcher CT/MR Shielded Applicator Set can detach its intrauterine tube tip, which may remain within a patient.

Moderate risk, FDA, Device defect

4 recalls

KL Owen Custom Orthodontic Solution

The orthodontic solution has a product error defect that may cause incorrect bracket placement.

Moderate risk, FDA, Device defect

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

The assay has a potential for intermittent well-to-well bias.

Moderate risk, FDA, Device defect

Medline Convenience Kits

Medline Convenience Kits contain temperature probes with an error in their distribution control process.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Intracept Access Instruments

Intracept Access Instruments may have a sterile barrier breach, which could lead to severe infection.

Moderate risk, FDA, Sterility problem

1 recall

Olympus Single Use Distal Cover

The Olympus Single Use Distal Cover has a newly designed replacement version.

Moderate risk, FDA, Device defect

6 recalls

Zimmer Biomet A.T.S. 4000 TS Tourniquet System Sterile Hoses

Sterile tourniquet hoses may have a sterility breach, potentially causing moderate localized infection.

Moderate risk, FDA, Sterility problem

GORE TAG Thoracic Branch Endoprosthesis Side Branch Component

The GORE TAG Thoracic Branch Endoprosthesis Side Branch Component can separate from its catheter.

Moderate risk, FDA, Device defect

Bard Catheters, Dialysis Catheters, and Biopsy Trays

The lidocaine ampoules in these devices were manufactured under deficient practices and are being recalled by the supplier.

Moderate risk, FDA, Manufacturing problem

Medtronic Harmony Delivery Catheter System

The Medtronic Harmony Delivery Catheter System may have an increased potential for distal tip detachment under certain conditions.

High risk, FDA, Manufacturing problem

Solar GI System (Water Perfusion)

The Solar GI System can accumulate moisture inside its tubing or sensors, affecting airflow or pressure measurement.

Moderate risk, FDA, Device defect

Covidien Shiley Disposable Decannulation Plug

The Covidien Shiley Disposable Decannulation Plug has incorrect labeling that includes a symbol for non-DEHP, but the product contains DEHP.

Moderate risk, FDA, Labeling error

8 recalls

Zeiss Intrabeam Spherical Applicator 1.5 cm

The Zeiss Intrabeam Spherical Applicator 1.5 cm failed to meet manufacturing specifications.

Moderate risk, FDA, Quality testing problem

Siemens ARTIS Icono Ceiling

The ARTIS icono ceiling has a potential issue with the suspension that holds the monitor, and screws may loosen over time.

Moderate risk, FDA, Device defect

RaySearch RayCare Oncology Information Systems

Beam set delivery note issues can cause data loss if the note is modified simultaneously or updated during a treatment session.

Moderate risk, FDA, Device defect

Hillrom Volara Circuit Kits

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.

High risk, FDA, Device defect