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Medical device recalls

Medical device recalls from FDA, newest first.
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3 recalls

Bard Broviac Single-Lumen CV Catheter Cutdown Tray

The Broviac catheter tray has damage to its outer tray that can compromise the sterile barrier.

Moderate risk, FDA, Sterility problem

Medline IV Administration and Extension Sets

IV administration and extension sets may leak, crack, or break, causing treatment delays, blood loss, infection, air embolism, or underdosage.

Moderate risk, FDA, Device defect

2 recalls

Philips Azurion Systems

Azurion systems may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

Moderate risk, FDA, Device defect

Laerdal Compact Suction Unit 4 RTCA Version

The Laerdal Compact Suction Unit 4 RTCA version may emit electromagnetic noise beyond acceptable limits.

Moderate risk, FDA, Device defect

1 recall

Elekta Leksell GammaPlan Radionuclide RT Treatment Planning System

Leksell GammaPlan treatment planning software has an error that may cause incorrect patient location irradiation.

Moderate risk, FDA, Device defect

2 recalls

Straumann WB Impression Post Closed Tray

The impression post closed tray contains magenta caps instead of brown.

Low risk, FDA, Device defect

Medline Medical Convenience Kits

Medline medical convenience kits may have an open seal on the packaging of the applicators.

Moderate risk, FDA, Device defect

5 recalls

Trividia Health TRUE METRIX Blood Glucose Meter Owner's Booklets and Instructions

The labeling for True Metrix blood glucose meters does not adequately explain the E-5 error code, which could delay treatment.

High risk, FDA, Labeling error

Philips Brilliance iCT and Spectral CT Scanners

Spectral CT 7500 on Rails may have fasteners not torqued to specification, potentially causing rotor parts to become unsecured and expelled.

Moderate risk, FDA, Device defect

Hologic Brevera Breast Biopsy System Disposable Needle

The Brevera Breast Biopsy System Disposable 9 Gauge Needle contains particulates that can be deposited into breast tissue during use.

Moderate risk, FDA, Foreign object

Medline ReNewal Reprocessed Diagnostic Catheters

Reprocessed catheters may contain small particles of residual material.

High risk, FDA, Foreign object

Medline Suction Catheter Kits and Intubation Tray

Medline Suction Catheter Kits and Intubation Tray may contain a smaller 8 Fr catheter, which can cause airway obstruction.

Moderate risk, FDA, Device defect

5 recalls

Olympus Sphincterotomes

Single Use 3-Lumen Sphincterotome V devices may deform and lose performance.

Moderate risk, FDA, Device defect

Maquet Cardiopulmonary Bubble Sensor

The Bubble Sensor has a durability issue with its connecting cable that can cause damage or loose contact.

Moderate risk, FDA, Device defect

Molift Mover 205, Mover 300 and Sling Bars

The Molift Mover 205, Mover 300, and sling bars can have a broken bolt that limits joint mobility.

Moderate risk, FDA, Device defect

Fujirebio Lumipulse G Plasma Assays, Calibrators and Controls

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging.

Moderate risk, FDA, Device defect

Boston Scientific AXIOS and HOT AXIOS Stent and Delivery Systems

AXIOS Stent and Electrocautery-Enhanced Delivery Systems may have deployment and expansion issues.

High risk, FDA, Device defect

1 recall

Vortex Surgical Ophthalmic Surgical Instruments

Volk Single Use Vitrectomy Lenses may have voids in the seal of Tyvek pouches, which could lead to infection.

Moderate risk, FDA, Sterility problem

1 recall

Siemens SOMATOM X.Ceed and NAEOTOM Alpha Software Applications

CT software applications lack FDA clearance and may be removed from certain systems.

Moderate risk, FDA, Software defect

6 recalls

VITEK 2 Gram-negative Susceptibility Cards

Issue may lead to QC failure or false resistant results.

Moderate risk, FDA, Device defect

Vantive Prismaflex and Oxiris Dialyzer Sets

The Prismaflex Set deaeration chamber may dislodge from the Control Unit.

Moderate risk, FDA, Device defect

Encore Medical EMPOWR Knee and Hip Implants

Empowr Acetabular System and Empowr 3D Knee Tibial Insert may have a packaging discrepancy that could cause surgical delay or revision surgery.

Moderate risk, FDA, Packaging defect

Medtronic MiniMed 780G Insulin Pump

A software issue may cause Pump Error 43 or 41, suspending insulin delivery.

Moderate risk, FDA, Software defect

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

LimFlow Vector

The LimFlow Vector has an incorrect expiration date.

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

2 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

NIPRO Conductivity Standard Solutions

Conductivity Standard Solution has a defect that can cause incorrect conductivity values for dialysate.

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

4 recalls

Edan Fetal, Maternal, Vital Signs and Patient Monitors

As a result of receiving an FDA It Has Come to Our Attention Letter (Ihctoa Letter) regarding potential cybersecurity issues with various of the firm device.

Moderate risk, FDA, Software defect

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

1 recall

Tyber Medical VOLT Wrist Treatment System Distal Radius Plates

The VOLT Wrist Treatment System plates have incorrect thread orientation, which can cause a problem.

Moderate risk, FDA, Device defect

7 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

Medline Semi Electric and Full Electric Homecare Beds

Medline beds have a potential hazard involving the hand control pendant and wires, which may overheat and pose a fire risk.

High 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