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Medical device recalls

Medical device recalls from FDA, newest first.
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6 recalls

BOBBY Balloon Guide Catheter

The BOBBY Balloon Guide Catheter has an increased rate of balloon pinhole defects.

Moderate risk, FDA, Device defect

3 recalls

Contego Medical Neuroguard IEP Carotid Stent and Balloon System

The Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System may fail to open its integrated filter.

Moderate risk, FDA, Device defect

TISSIUM COAPTIUM Connect Peripheral Nerve Repair Devices

Currently labeled shelf life of 36 months is not substantiated by real-time data.

Moderate risk, FDA, Labeling error

Instrumentation Laboratory GEM Premier 7000 and GEM Premier 5000 Blood Analyzers

The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 and GEM Premier 5000 PAK lots did not meet established manufacturing specifications.

Moderate risk, FDA, Device defect

5 recalls

Medline Hudson RCI Heated Neonatal Breathing Circuits

Neonatal and infant heated wire breathing circuits may experience sporadic failure.

Moderate risk, FDA, Device defect

Siemens Healthcare Diagnostics Atellica CH Urine Albumin

Atellica CH Urine Albumin tests may cause falsely depressed urea nitrogen and hemoglobin A1c results.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan LabPro Panel Update Software

MicroScan LabPro V5.03 Panel Update 11 has incorrect algorithms that may affect antimicrobial susceptibility test results.

Moderate risk, FDA, Software defect

Aniara Diagnostica 5-PLASMA Bivalirudin Kits, Calibrators and Controls

The 5-Plasma Bivalirudin AMR Verification Kit has stability issues that degrade measurable bivalirudin.

Moderate risk, FDA, Quality testing problem

Philips Allura and Azurion X-Ray Systems

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Moderate risk, FDA, Device defect

4 recalls

GE Healthcare MAC VU360 Electrocardiographs

After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity.

Moderate risk, FDA, Software defect

Merge OrthoPACS and PACS

Merge PACS may show thumbnails from a previous patient study while another is open.

Moderate risk, FDA, Device defect

Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls have out-of-specification sodium azide concentration, causing low health risk.

Low risk, FDA, Quality testing problem

Happiest Baby Pre-Loved SNOO Smart Sleeper

The pre-loved SNOO Smart Sleeper failed to meet quality standards before distribution.

Moderate risk, FDA, Device defect

1 recall

Stryker Ahto Tube Sets and Suction/Irrigator Packaging

Stryker tube sets can leak from the handpiece during use.

Moderate risk, FDA, Device defect

5 recalls

Boston Scientific Radial Jaw 4 Biopsy Forceps

Radial Jaw 4 Standard Capacity Biopsy Forceps may have a breach in the sterile barrier of their packaging.

Moderate risk, FDA, Sterility problem

FORWARD Oral Airway Kit and Kingfisher Compact Individual First Aid Kit

The FORWARD Oral Airway Kit may have an occluded or partially occluded Guedel Airway tip.

Moderate risk, FDA, Device defect

Quantum Rehab Power Wheelchairs

Quantum Rehab powered wheelchairs may show reminder pop-ups while in use, which can cause an unexpected park brake stop and lead to a fall or injury.

Moderate risk, FDA, Device defect

Charger for the Therabody Theragun, G4 PRO Massage Device

The charger for the Theragun G4 PRO may overheat, posing a fire risk.

Moderate risk, FDA, Device defect

Normand Info REMISOL Advance Data Manager

REMISOL Advance Data Manager software may replace final combo test results with sub-results, causing incorrect reporting.

Moderate risk, FDA, Software defect

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

3 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

AMS Aligned Medical Solutions Medical Convenience Kits

Medical convenience kits contain Lidocaine HCl injection that may be affected by supplier quality issues.

Moderate risk, FDA, Packaging defect

Medtronic EOPA Arterial Cannulas

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

Moderate risk, FDA, Device defect

4 recalls

Argon Medical Devices L-Cath Catheters

L-Cath PICC S/L Peripherally Inserted Central Catheter may leak or crack at the hub, causing blood loss and infection.

Moderate risk, FDA, Device defect

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

2 recalls

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

4 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

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

3 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

Silent Nite Sleep Appliance

The Silent Nite Sleep Appliance lacks FDA clearance.

Moderate risk, FDA, Unapproved product

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

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