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Medical device recalls

Medical device recalls from FDA, newest first.
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11 recalls

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

AVID Medical Halyard LAVH Packs

The Halyard Lavh Pack with Clearify Visualization System may leak because the component was sterilized against manufacturer recommendation.

Moderate risk, FDA, Device 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

Arrowhead DE Arrow-LOK Implant

The Arrow-LOK Implant did not undergo required gamma radiation dose audit, which could lead to patient infection.

Moderate risk, FDA, Sterility problem

Kico Knee Innovation Arvis Surgical Navigation System GEN 2

The ARVIS surgical navigation system may show a tilted image due to an internal sensor issue.

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

EndoFLIP System

The EndoFLIP System can incorrectly flag catheters as expired, making them unavailable for clinical procedures.

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

2 recalls

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

BIOFIRE Respiratory Panel 2.1 (RP2.1)

BioFire Diagnostics is recalling its Biofire Respiratory Panel 2.1 because of increase in false negative results.

Moderate risk, FDA, Device defect

3 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

Spectra Medical Devices Sodium Chloride Injection

Sodium Chloride Injection, 0.9%, USP 10mL Ampule may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.

High risk, FDA, Sterility problem

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

1 recall

U2 Total Knee System Femoral Offset Bushings

Femoral offset bushings have incorrect engraved numbering that could cause incorrect implant orientation.

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

United Orthopedic U2 and USTAR II Knee Trial and Instrument Sets

Knee femur prosthesis trials and adaptors may not assemble properly due to an incomplete process of the component screw.

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

5 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

OXOS Medical MC2 Portable X-Ray System

The MC2 Portable X-Ray System has a defective circuit board that overheats.

Moderate risk, FDA, Device defect

Innovasis Vector Pedicle Screw System Anti-Torque

The anti-torque instrument may have an undersized condition that could prevent it from engaging with the screw, leading to surgical delay.

Moderate risk, FDA, Device defect

Nuclein DASH Rapid PCR Instrument

Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Moderate risk, FDA, Software defect

6 recalls

Halyard Cardiac Catheterization and Angiography Kits

Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

High risk, FDA, Foreign object

Munevo DRIVE and Munevo DRIVE R-Net Powered Wheelchair Hands-Free Control Application

A software issue may cause the wheelchair's driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.

Moderate risk, FDA, Software defect

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