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Medical device recalls

Medical device recalls from FDA, newest first.
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4 recalls

OBP Medical ER-Spec Single-Use Vaginal Speculum with LED Light Source

The ER-Spec vaginal speculum may have a burr on the blade, introducing a sharp edge for patients and providers.

Moderate risk, FDA, Device defect

Straumann GM Helix Dental Implants

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.

Moderate risk, FDA, Labeling error

Philips Allura Xper FD Interventional Fluoroscopic X-Ray Systems

Allura Xper FD has a firmware issue that could lead to loss of geometry movements.

Moderate risk, FDA, Software defect

Terumo Glidesheath Slender A-Kit

The Glidesheath Slender was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Moderate risk, FDA, Device defect

6 recalls

Thermo Fisher Diagnostics Neisseria Meningitidis Gp C Tests

Neisseria meningitidis Gp C 2ml/VL is not performing to IFU criteria, not positive to ATCC13102 within 60 seconds.

Moderate risk, FDA, Quality testing problem

Medline Micro-Kill Bleach Germicidal Bleach Wipes

Medline Micro-Kill Bleach Germicidal Bleach Wipes may have reduced bleach concentration before the end of their shelf life.

Moderate risk, FDA, Contamination

Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices

V-Loc 90 Absorbable Wound Closure Device may have a perforation or tear in its sterile barrier packaging, which may lead to infection or prolonged surgery.

Moderate risk, FDA, Sterility problem

Xhibit Central Station

The Xhibit Central Station has audio/video failures due to a display port component.

Moderate risk, FDA, Device defect

Roche Navify Digital Pathology Software

Navify Digital Pathology software has an image/metadata discrepancy with the Viewer window.

Moderate risk, FDA, Device defect

BOBBY Balloon Guide Catheter

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

Moderate risk, FDA, Device defect

3 recalls

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

Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis

The Blom-Singer Classic Indwelling Voice Prosthesis has incorrect labeling.

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

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

HardyDisk AST Cefiderocol 30µg (FDC30)

Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.

Moderate risk, FDA, Device defect

5 recalls

FilmArray NGDS Warrior Panel

The FilmArray NGDS Warrior Panel has mismatches between the outbreak strain and the reference strain used in its development.

Moderate risk, FDA, Device defect

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

2 recalls

Maquet Flow Anesthesia Machines

Events observed where anesthetic agent was not delivered when the vaporizer was activated.

Moderate risk, FDA, Device defect

Stryker Ahto Tube Sets and Suction/Irrigator Packaging

Stryker tube sets can leak from the handpiece during use.

Moderate risk, FDA, Device defect

4 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

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

2 recalls

SeaSpine OsteoBallast and Ballast Bone Grafts

The products were filled with approximately 4.5 cc DBM instead of approximately 7.5 cc DBM.

Moderate risk, FDA, Device defect

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

3 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

3 recalls

Medline Medical Convenience Kits

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

Moderate risk, FDA, Contamination

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

4 recalls

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

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

3 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