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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

Boston Scientific ENROUTE Transcarotid Neuroprotection System

The ENROUTE Transcarotid Neuroprotection System has a potential for arterial sheath tip separation during use.

High risk, FDA, Device defect

1 recall

Beckman Coulter DxC 500I Clinical Analyzer Modules

Beckman Coulter DxC 500i Clinical Analyzer Modules have a software defect that can cause erroneous patient test results.

Moderate risk, FDA, Software defect

7 recalls

Paragon 28 Navicular Cage Foot Implants

The foot implant has elevated oxygen levels that may reduce material ductility.

Low risk, FDA, Device defect

Blanketrol II, Blanketrol III, and Innercool Coolblue Console

The Blanketrol II thermal regulating system may shut down due to overheating of its 115V CPU board.

Moderate risk, FDA, Device defect

Paragonix Technologies KidneyVault Portable Renal Perfusion System

The KidneyVault Portable Renal Perfusion System may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Moderate risk, FDA, Software defect

Boston Scientific OverStitch Suture Cinch and Suture Cinch Long

The OverStitch Suture Cinch may fail to deploy the cinch implant or cut the suture.

Moderate risk, FDA, Device defect

Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device

The TD Navio Midi Speech Generating Device may have damaged battery mounting tabs, causing internal short circuit and heating.

Moderate risk, FDA, Device defect

Philips Cardiac Workstation 5000 and 7000

The Cardiac Workstation 5000 may provide inaccurate heart rate data.

Moderate risk, FDA, Device defect

Dentsply Sirona Capsule Mixer

The Dentsply Sirona Capsule Mixer can discharge electricity when unplugged.

Moderate risk, FDA, Device defect

2 recalls

Cardinal Health Presource Kits

Procedure kits contain neurological sponges with unexpected variability in endotoxin levels.

Moderate risk, FDA, Contamination

BD Intravascular Administration and Extension Sets

Intravascular administration sets may not have received adequate sterilization processing.

Moderate risk, FDA, Sterility problem

1 recall

Erbe USA ERBECRYO 2 Cryosurgical Unit

The ERBECRYO 2 Cryosurgical Unit can rupture its cryoprobe due to excessive pressure from a strong pull on the hose.

Moderate risk, FDA, Device defect

2 recalls

Straumann Bone Level Tapered (BLT) Implant

The Straumann Bone Level Tapered Implant may contain implants that are 12mm instead of 14mm.

Moderate risk, FDA, Labeling error

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter

The Baxter Duo-Vent Solution Set and Male Luer Lock Adapter can have air bubbles in the drip chamber and tubing.

High risk, FDA, Device defect

2 recalls

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

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

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

3 recalls

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

1 recall

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

1 recall

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

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

1 recall

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

2 recalls

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

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

2 recalls

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