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Medical device recalls

Medical device recalls from FDA, newest first.
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3 recalls

Agiliti Adapt Pump

The Adapt Pump may not re-engage the Microclimate Management function after using Autofirm for 10 minutes.

Moderate risk, FDA, Device defect

3 recalls

Medline Kits with Tego Connectors

Medline kits containing Tego Connectors may have silicone seal issues that can cause fluid leakage or air infusion.

Moderate risk, FDA, Contamination

Encore Medical Reverse Shoulder Prosthesis and EMPOWR 3D Knee Inserts

Knee and humeral socket implants contain incorrect labeling.

Moderate risk, FDA, Labeling error

PIE PAK and Trolley System

The PIE Trolley System lacks 510K clearance.

Moderate risk, FDA, Unapproved product

4 recalls

Medline Sterile Saline Wound Wash and Convenience Kits

Medline Sterile Saline Wound Wash may not meet sterility requirements.

Moderate risk, FDA, Sterility problem

MRIMed MRI LED Mobile Exam Light Battery

Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

Moderate risk, FDA, Device defect

Olympus Resection and Inner Sheaths

Olympus Resection and Inner Sheaths have a ceramic tip that may break.

Moderate risk, FDA, Device defect

Olympus Cystoscope Outer Sheath

The Olympus Cystoscope Outer Sheath is being removed due to incompatibility with a GreenLight Laser that could damage the device tip.

Moderate risk, FDA, Device defect

1 recall

Olympus High Flow Insufflation Unit

The Olympus High Flow Insufflation Unit has a software issue that may lead to overpressure events.

High risk, FDA, Software defect

5 recalls

Medline Convenience Kits and Surgical Drapes

Medline Convenience Kits and Surgical Drapes may not be sterile due to calibration issues in sterilization equipment.

Moderate risk, FDA, Sterility problem

Auris Health MONARCH Bronchoscopy Platform

Monarch Platform, Bronchoscopy has a software issue that may cause unanticipated robotic arm positioning.

Moderate risk, FDA, Software defect

Stryker MOLLI 2 System, Introducers, Wand, OncoPen and Tablet

The Molli 2 System needs updated labeling because magnetized surgical tools can dislodge markers during tissue removal.

Moderate risk, FDA, Labeling error

Olympus Thunderbeat Surgical Devices

Firm is initiating a removal due to continued reports of adverse events.

Moderate risk, FDA, Device defect

Centinel Spine Prodisc C SK Total Cervical Disc Replacement

Prodisc C SK total cervical disc replacement was mislabeled as the 6mm product but included the 5mm product.

Moderate risk, FDA, Labeling error

3 recalls

MediHoney Gel and Calcium Alginate Dressings

MediHoney dressings and gel may have packaging failures that could breach the sterile barrier.

Moderate risk, FDA, Sterility problem

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

1 recall

Steris Barco MNA with HexaVue IP Integration System

The Barco MNA with the HexaVue IP Integration System may have an incorrect configuration file.

Moderate risk, FDA, Device defect

3 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

ATEC Lateral Navigation Disc Prep Instruments

ATEC Lateral Navigation Disc Prep Instruments have a design issue with incorrect navigated array connection geometry.

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

4 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

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

3 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

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

5 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

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

1 recall

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

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

2 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

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