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Medical device recalls

Medical device recalls from FDA, newest first.
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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

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

3 recalls

Daavlin Photera Phototherapy Devices

The Photera 400 phototherapy device has incorrect UV sensor gain.

Moderate risk, FDA, Device defect

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

5 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

2 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

3 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

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

7 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

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

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

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

4 recalls

Medline Convenience Kits

Medline Convenience Kits contain lidocaine and bupivacaine injections with quality issues.

High risk, FDA, Device defect

GE Healthcare AW Server 3.2 ext.6.5

The AW Server may open the previous patient's exam instead of the intended one, potentially leading to misdiagnosis.

Moderate risk, FDA, Device defect

Octopus 4, Evolution, and Evolution AS Tissue Stabilizer

The Octopus Evolution Tissue Stabilizer has an assembly issue where tubing was incorrectly positioned.

Moderate risk, FDA, Manufacturing problem

Stryker Neurovascular Inzone Detachment System

The INZONE DETACHMENT SYSTEM may experience premature battery drain, causing it to not power on or be unable to detach a coil.

Moderate risk, FDA, Device defect

1 recall

Zimmer Off-Axis Comprehensive Shoulder System Reamer Guides

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Moderate risk, FDA, Device defect

1 recall

Philips Avalon Fetal Monitor

The Philips Avalon Fetal Monitor has incorrect speaker connector assembly that can cause loss of speaker output.

Moderate risk, FDA, Device defect

4 recalls

STAAR ICL Calculation Software

The STAAR ICL Calculation Software has a coding issue that affects the implant orientation diagram printout.

Moderate risk, FDA, Software defect

Inspire Respiratory Sensing and Stimulation Lead

The Inspire Respiratory Sensing Lead has an incorrect Use By Date, which may lead to unplanned revision surgery.

Moderate risk, FDA, Labeling error

Merit Medical Systems Splashwire Hydrophilic Guide Wire

The Splashwire Hydrophilic Guide Wire has unsealed portions of pouches.

Moderate risk, FDA, Packaging defect

Beta Bionics iLet Bionic Pancreas

This can lead to hyperglycemia.

Moderate risk, FDA, Software defect

4 recalls

Medline Urethral Catheters and Procedure Kits

Medline urethral catheters and kits may have surface irregularities or connector issues.

Moderate risk, FDA, Quality testing problem

GE HealthCare Giraffe OmniBed Devices

The Giraffe OmniBed has a potential issue with the canopy soffit that could cause patient injury.

Moderate risk, FDA, Device defect