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Medical device recalls

Medical device recalls from FDA, newest first.
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4 recalls

AMS Aligned Medical Solutions Surgical Procedure Packs

Medical convenience kits contain neurological sponges with potentially variable endotoxin levels.

Moderate risk, FDA, Sterility problem

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

6 recalls

Medline Medical Convenience Kits

Medline medical convenience kits may be contaminated with low levels of Bacillus species.

Moderate risk, FDA, Contamination

Medline Convenience Kits Containing Bard Silastic Foley Catheters

Medline convenience kits contain Bard Silastic Foley Catheters with increased raw material on the surface, which may be harmful.

Moderate risk, FDA, Device defect

Medline Hip and Knee Procedure Kits

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

High risk, FDA, Device defect

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

Karl Storz Flexible Hystero-Fiberscope Kits

Flexible Hystero-Fiberscope Kits may contain an expired seal, impacting sterility assurance.

Moderate risk, FDA, Sterility problem

SafeOp Patient Interface

The device may experience loss or interruption of triggered electromyography functionality during use.

Moderate risk, FDA, Software defect

7 recalls

SnapshotGLO Wound Imaging Device

The SnapshotGLO Wound Imaging Device can become temporarily unusable when its battery fully discharges into shipping mode.

Moderate risk, FDA, Software defect

Pipeline Flex Embolization Device with Shield Technology

Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

Moderate risk, FDA, Labeling error

Medline Convenience Kits

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

High risk, FDA, Device defect

AVID Medical Halyard Standard Line Insertion Pack

The Halyard STANDARD LINE INSERTION PACK has defective silicone seals that may cause fluid occlusion or leakage.

Moderate risk, FDA, Device defect

Emano Flow

The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.

Moderate 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

5 recalls

Medtronic Ventriculostomy Kit

Ventriculostomy kits may have endotoxin levels above the acceptable limit, which can cause an acute inflammatory process.

Moderate risk, FDA, Contamination

Penumbra System RED 68 Reperfusion Catheter

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

Moderate risk, FDA, Manufacturing problem

Wilcox BOSS Xe Family

The BOSS Xe family has a software enhancement to increase safety and all units should be returned.

Moderate risk, FDA, Software defect

3mensio Workstation (Vascular Fenestrated) Software

The software may report a measurement larger than the actual anatomical dimension.

Moderate risk, FDA, Software defect

Silent Nite Sleep Appliance

The Silent Nite Sleep Appliance lacks FDA clearance.

Moderate risk, FDA, Unapproved product

4 recalls

Olympus 4K UHD LCD Monitor

The Olympus 4K UHD LCD Monitor can have faulty HDMI and DisplayPort connectors, causing image loss or abnormalities.

Moderate risk, FDA, Device defect

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

AVID Medical Halyard Eye Pack Convenience Kit

The Halyard Eye Pack Convenience kit contains an incorrect concentration of Betadine solution.

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

5 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

Boston Scientific FARASTAR Ablation Generator and Cardiac Ablation Catheter

The Farastar Ablation Generator has a configuration not compatible with the Farapoint catheter.

Moderate risk, FDA, Device defect

Boston Scientific FARASTAR Ablation Generators and Cardiac Ablation Catheters

Farastar ablation generators and catheters have labeling that does not include Farapoint PFA catheter information.

Moderate risk, FDA, Labeling error

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

6 recalls

Daavlin Photera Phototherapy Devices

The Photera 400 phototherapy device has incorrect UV sensor gain.

Moderate risk, FDA, Device defect

Medline Kits Containing Zimmer Biomet Mixing Bowls and Spatulas

Medline kits with Zimmer Biomet mixing bowls and spatulas have seal nonconformities risking sterility breach.

Moderate risk, FDA, Sterility problem

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

Medtronic DLP and Bio-Medicus Cannulas

The Medtronic DLP One-Piece Pediatric Arterial Cannula may contain loose foreign material with trace blood.

Moderate risk, FDA, Foreign object

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

7 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

Oscor Abiomed Impella Introducer Kits

The introducer kit for the Impella system may leak from the sidearm, under the sheath cap, and along hub score lines.

High risk, FDA, Manufacturing problem

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

6 recalls

Versius Surgical System

The Versius Surgical System has a cybersecurity risk because Secure Boot was not enabled.

Moderate risk, FDA, Software defect

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

Vitek 2 AST-N447 Test Kit

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

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