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Medical device recalls

Medical device recalls from FDA, newest first.
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4 recalls

Aesculap MINOP Trocar

The Minop Trocar 150MM 4 Wking CHANNEL6.0MM may have a trocar shaft that is too long.

Moderate risk, FDA, Device defect

Atellica CH Urine Albumin (UAlb)

Atellica CH Urine Albumin may report falsely depressed results for samples above 40.0 mg/dL.

Moderate risk, FDA, Device defect

4 recalls

Impella RP

The Impella RP devices have a sensor that may malfunction, causing sensor values to drift.

High risk, FDA, Device defect

Cobas Pro Integrated Solutions with Cobas C 503 analytical Units

The cobas pro integrated solutions with cobas c 503 analytical units have a software defect that can cause erroneous patient results.

Moderate risk, FDA, Software defect

GE Healthcare Centricity Universal Viewer Zero Footprint Client

The viewer may show patient information that does not match the images displayed.

Moderate risk, FDA, Device defect

Olympus ShockPulse-SE Lithotripsy System Reusable Probes, Single Use Probes and Generator

The ShockPulse-SE Lithotripsy System can remain in a blinking phase waiting to recognize the transducer due to damage to the plug or receptacle.

Moderate risk, FDA, Device defect

3 recalls

Medtronic Octopus Nuvo Tissue Stabilizer

The Octopus Nuvo Tissue Stabilizer has tubing incorrectly positioned, which may cause assembly issues.

Moderate risk, FDA, Manufacturing problem

Remel Campy CVA Medium

Campy CVA Medium may have low recovery of Campylobacter Jejuni.

Moderate risk, FDA, Device defect

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

5 recalls

Medline Sterile Saline Wound Wash and Convenience Kits

Medline Sterile Saline Wound Wash may not meet sterility requirements.

Moderate risk, FDA, Sterility problem

Hitachi Proton Beam Therapy

The Hitachi Proton Beam Therapy System has a software anomaly in its patient positioning system that may cause positional discrepancy.

Moderate risk, FDA, Software defect

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

2 recalls

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

Intuitive Surgical Da Vinci 5 Console

The Da Vinci 5 surgical system can have an error event causing loss of user interface content on a monitor.

Moderate 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

7 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

Spectrum IQ Infusion Pump

The Spectrum IQ Infusion Pump was released without full testing, including occlusion alarm testing.

Moderate risk, FDA, Device defect

Wilson-Cook Teslatome Bipolar Sphincterotomes

Teslatome Bipolar Sphincterotomes may have a void in material separating wire guide and cutting wire lumens, causing inappropriate current path during cutting.

Moderate risk, FDA, Device defect

Immunotech Estrone RIA

Estrone RIA may rarely give falsely high patient results, which might cause temporary injury.

Moderate risk, FDA, Device defect

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

Medica Capillary Tubes and EasyBloodGas/EasyStat Capillary Tube Kit

Medica Capillary Tubes can falsely elevate potassium results in patient samples.

Moderate risk, FDA, Device defect

3 recalls

Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display

The da Vinci 5 Surgeon Console Viewer Display has outdated firmware that may cause loss of 3D or complete visualization, potentially leading to injury.

Moderate risk, FDA, Software defect

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

Surepulse VS Newborn Heart Rate Monitor Caps

Surepulse VS Cap has incorrect sizing guide on its label.

Low risk, FDA, Labeling error

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

3 recalls

Halyard Transport Bag Kit

The Halyard TRANSPORT BAG KIT has a Tyvek bag seal issue that may compromise sterility.

Moderate risk, FDA, Sterility problem

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

7 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

FUJIFILM FDR Visionary Suite

The FDR Visionary Suite X-ray high-voltage generator can overheat and damage surrounding parts, possibly causing smoke.

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