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Medical device recalls

Medical device recalls from FDA, newest first.
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5 recalls

Da Vinci X, Xi, and 5 Surgical Systems

The da Vinci surgical systems have a software error that can allow failing instrument arms to remain in use.

Moderate risk, FDA, Software defect

Tornier Perform Reversed Perip Screw

Screws labeled 5.0mmx18mm are actually 5.00mmx14mm, which may cause a delay or increase risk of failure.

Moderate risk, FDA, Labeling error

2 recalls

Beckman Coulter DxH Diluent and DxH ECO Diluent

Coulter DxH Diluent and ECO Diluent can cause elevated platelet background counts with use.

Moderate risk, FDA, Device defect

Olympus Single Use Electrosurgical Knives KD-640L and KD-645

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Moderate risk, FDA, Device defect

2 recalls

Philips Ingenia, MR 7700 and Evolution MR Systems

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Moderate risk, FDA, Device defect

Miach Orthopaedics BEAR Implant

The BEAR Implant has an incorrect expiration date on its label.

Moderate risk, FDA, Labeling error

3 recalls

Broselow Pediatric Emergency Tape and Organizers

Broselow Pediatric Emergency Tape and Organizers contain potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

High risk, FDA, Device defect

Medline Medical Procedure Convenience Kits

Medline medical procedure convenience kits contain a liquid adhesive whose tubing can crack during actuation.

Moderate risk, FDA, Device defect

Cardinal Health Chest Drainage Units and Accessories

Chest drainage units may not show tidaling or bubbling when used on infants, which could lead to inadequate treatment.

Moderate risk, FDA, Device defect

3 recalls

Canon Alphenix Interventional Fluoroscopic X-Ray Systems

As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed.

Moderate risk, FDA, Device defect

Gold Star Distribution Bandages, Condoms, Feminine Hygiene Products, Toothbrushes and Pregnancy Tests

Gold Star Distribution tests may have been exposed to rodents and rodent activity.

Moderate risk, FDA, Foreign object

Siemens LUMINOS Q.Namix R and Q.Namix T Interventional Fluoroscopic X-Ray Systems

Interventional fluoroscopic X-ray systems may not flip ortho images and could process a previous patient's image.

Moderate risk, FDA, Device defect

1 recall

Cerapedics PearMatrix P-15 Peptide Enhanced Bone Graft

The bone graft has an incorrect expiration date.

Moderate risk, FDA, Labeling error

3 recalls

Community Products Rifton Equipment TRAM and E-Pacer Powered Lifts

The TRAM and E-Pacer have a potential for fraying on the body support strap.

Moderate risk, FDA, Device defect

GVS TM SQ40S Blood Transfusion Filter

The SQ40S Blood Transfusion Filter was released before quality control was complete, so sterility cannot be confirmed.

Moderate risk, FDA, Sterility problem

Philips Patient Information Center iX

The Patient Information Center iX software can modify event notification settings without user indication.

Moderate risk, FDA, Software defect

3 recalls

Beckman Coulter LDL-Cholesterol Assay

Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU).

Moderate risk, FDA, Device defect

Sysmex America TS-10/TS-10H Tube Sorter

The TS-10/TS-10H Tube Sorter may unexpectedly disengage its lift, causing unintended downward movement.

Moderate risk, FDA, Device defect

Intuitive Surgical Ion Endoluminal System Vision Probe Bags

The Ion Vision Probe Bag may have a compromised or incomplete sterile pouch seal.

Moderate risk, FDA, Sterility problem

6 recalls

ICU Medical Plum Duo and Plum Solo Infusion Pumps

ICU Medical Plum Duo and Plum Solo Infusion Pumps can prevent programming a piggyback flush, causing a violation message.

Moderate risk, FDA, Software defect

Merit Medical Inflation Devices and Custom Kits

Inflation device handle may detach from the syringe during procedure.

Moderate risk, FDA, Device defect

ICU Medical Tego Connector

The Tego Connector has a silicone seal that may bulge, separate, or tear, causing fluid leaks and therapy interruption.

Moderate risk, FDA, Contamination

Baxter SIGMA Spectrum Infusion Pump

The SIGMA Spectrum Infusion Pump has defective grease that may cause over-infusion or free-flow.

Moderate risk, FDA, Device defect

Mazor Robotics Mazor X Robotic Guidance System

The Mazor X robotic guidance system has software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Moderate risk, FDA, Software defect

GE Healthcare Omni Legend PET Scanners

Omni Legend systems may show a streaking artifact in PET scan images.

Moderate risk, FDA, Device defect

7 recalls

Thoratec CentriMag Blood Pump and Kits

The CentriMag blood pump may not fit into the motor and may not lock securely, which could lead to stroke, embolism, or death.

Moderate risk, FDA, Foreign object

Hologic ThinPrep CytoLyt Solution Buffered Cell Wash Solution

ThinPrep CytoLyt Solution, a buffered cell wash solution, is contaminated with Parengyodontium album.

Moderate risk, FDA, Contamination

ICU Medical Plum Duo Infusion System

The Plum Duo Infusion System may fail to produce audible alarms, alerts, or feedback for touchscreen inputs.

Moderate risk, FDA, Device defect

Medtronic Abre Venous Self-Expanding Stent System

The Abre Venous Self-Expanding Stent System may have a Nitinol anomaly causing reduced stent diameter and radial force, potentially leading to migration.

Moderate risk, FDA, Device defect

Instrumentation Laboratory Coagulation Testing Reagents

The product has potential for microbial contamination.

Moderate risk, FDA, Contamination

ICU Medical Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray

Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray may have cracked syringe collars, leading to delayed or repeated blood draw or fluid leakage.

Moderate risk, FDA, Device defect

Intuitive Surgical da Vinci SP Access Port Kit

The da Vinci SP Access Port Kit may develop cracks, potentially causing a sterility breach.

Moderate risk, FDA, Sterility problem

3 recalls

Philips Azurion Systems

Philips Azurion Systems R3.0 have software issues that may cause loss of X-ray and other problems.

Moderate risk, FDA, Software defect

Philips Azurion Systems

Philips Azurion Systems have software issues that may cause system restarts and positional errors.

Moderate risk, FDA, Software defect

Medline Medical Procedure Convenience Kits

Medline medical procedure convenience kits can leak and emit vaporized saline that resembles smoke during use.

Moderate risk, FDA, Device defect

1 recall

Philips Allura Xper FD10, FD20 and Biplane Systems

Philips Allura Xper systems may have a missing drip tray, allowing coolant to contact electrical components and cause short-circuits.

Moderate risk, FDA, Device defect

2 recalls

Fresenius Kabi Ivenix Infusion System LVP Software

The Ivenix Infusion System LVP Software has instructions for LVP duration programming that are emphasized in the IFU.

Moderate risk, FDA, Software defect

Medline Kits With B. Braun IV Administration Sets

Medline kits containing B. Braun IV administration sets may have check valves that stick.

Moderate risk, FDA, Device defect

4 recalls

Medicrea IB3D Universal Implant Inserter and PL Instruments Set

Medicrea IB3D Universal Implant Inserter and PL Instruments Set may have a handle that untreads, causing inability to rotate implant.

Moderate risk, FDA, Device defect

Medtronic Vanta Clinician Programmer Application

The A71200 Vanta Clinician Programmer Application may not function as intended, potentially causing a prolonged or postponed surgical procedure.

Moderate risk, FDA, Device defect

Mobius Imaging AIRO Computed Tomography X-Ray System Pendants

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Moderate risk, FDA, Labeling error

Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters

The Coyote balloon catheter may not inflate or deflate properly during use.

Moderate risk, FDA, Device defect

7 recalls

BD Pyxis ES Enterprise Server

BD Pyxis ES Enterprise Server has a software issue that may result in equipment not receiving timely updates of patient, medication, or related information.

Moderate risk, FDA, Software defect

Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor and USB 2-Channel IBP Module

Philips Tempus Pro Patient Monitor measures ICP and BDR but these measurements are unvalidated, potentially leading to incorrect clinical decisions.

Moderate risk, FDA, Device defect

Integra LifeSciences Codman Microsensor and CereLink ICP Sensor Basic Kits

The Codman Microsensor Basic Kit may have corrosion stains on its included needle.

Moderate risk, FDA, Device defect

Securitas Arial 900 MHz Call Stations

Arial 900 MHz Call Stations may fail to transmit a low battery alert before battery failure.

Moderate risk, FDA, Software defect

Medline Hudson RCI Medium Concentration Oxygen Masks

Medline Hudson RCI Medium Concentration Oxygen Masks can have tubing disconnect, delaying patient care and causing shortness of breath.

Moderate risk, FDA, Device defect

IMRIS HFD100 Head Fixation Device

The Head Fixation Device HFD100 has a torque screw that may crack or separate, risking patient injury.

Moderate risk, FDA, Device defect

Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

Moderate risk, FDA, Device defect

1 recall

Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems

Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.

Moderate risk, FDA, Device defect