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Medical device recalls

Medical device recalls from FDA, newest first.
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3 recalls

Silent Nite Sleep Appliance

The Silent Nite Sleep Appliance lacks FDA clearance.

Moderate risk, FDA, Unapproved product

1 recall

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

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

4 recalls

Think Surgical TMINI Femur and Tibia Tracking Arrays

The TMINI Femur and Tibia Tracking Arrays may loosen at the knob, causing misalignment.

Moderate risk, FDA, Device defect

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

5 recalls

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

Fresenius Medical Care 5008X Blood Tubing Sets

5008X Blood Tubing Set may have connection issues that can cause online port errors.

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

Encore Medical EMPOWR 3D Knee Implants

The knee device has a packaging discrepancy with incorrect product size mixed up.

Moderate risk, FDA, Packaging defect

2 recalls

ConvaTec Aquacel Ag Surgical SP

Surgical dressing manufactured out of specification (greater thickness).

Moderate risk, FDA, Quality testing problem

Olympus Single Use Distal Cover

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

Moderate risk, FDA, Device defect

7 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

Masimo Radius VSM ECG Sets and NIBP Cuffs

Radius VSM ECG pre-connected Set and Disposable NIBP Cuff may have issues that could delay treatment or cause skin irritation.

Moderate risk, FDA, Device defect

10 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

Medela ENFit Enteral Extension Sets

The ENFit ExSet Strl 60 2.0ml PV 1ct EN may have incorrect connectors, causing misconnection and delivery delays.

Moderate risk, FDA, Device defect

Siemens ARTIS Icono Biplane, Ceiling and Floor

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Moderate risk, FDA, Device defect

Accuray CyberKnife Treatment Delivery System and Linear Accelerator

The Cyberknife system's collimator may not fully dock, triggering an interlock and preventing motion.

Moderate risk, FDA, Device defect

Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators

Potential sterile breach of the pouches in which devices are packaged.

Moderate risk, FDA, Sterility problem

Hamilton Medical IntelliCuff Portable Automatic Cuff Pressure Controller

The IntelliCuff portable automatic cuff pressure controller may alarm with a leakage error and fail to maintain pressure.

Moderate risk, FDA, Device defect

Pilling Wecksorb Neurosponges and Neurosponge Strips

Pilling Wecksorb Neurosponges and Neurosponge Strips may have out-of-specification levels of endotoxins.

Moderate risk, FDA, Quality testing problem

2 recalls

Remel GC Agar Base

GC Agar Base may have reduced or no recovery of some strains of Neisseria gonorrhoeae.

Moderate risk, FDA, Device defect

Hamilton Medical Coaxial Breathing Circuit Sets

The coaxial breathing circuit may have expiratory valve membranes sticking, causing an exhalation obstructed alarm and inadequate ventilation.

High risk, FDA, Device defect

1 recall

Medline Convenience Kits

Medline Convenience Kits contain lidocaine ampules with quality issues that may affect their use.

Moderate risk, FDA, Device defect

2 recalls

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Convenience kits with 10mL polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product