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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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2 recalls that day

Luminex LIAISON PLEX Gram-Negative Blood Culture Assay

The Liaison Plex Gram-Negative Blood Culture Assay may cause incorrect or delayed diagnosis of bloodstream infection.

Moderate risk, FDA, Device defect

Halyard Arthroscopy Pack

The Halyard Arthroscopy Pack is mislabeled as "Extremity" instead of "Arthroscopy Pack."

Moderate risk, FDA, Labeling error

2 recalls that day

GE Senographe Pristina Mammography Systems

GE Senographe Pristina Mammography Systems may show collimator blades or open more than expected in 3D+2D manual mode.

Moderate risk, FDA, Device defect

Intelerad IntelePACS Software

IntelePACS software has a cybersecurity vulnerability that could allow a malicious user to take over an administrator session.

Moderate risk, FDA, Software defect

9 recalls that day

Remel Yeastone Broth

Yeastone Broth may report false susceptibility to antifungal agents.

Moderate risk, FDA, Quality testing problem

Baxter TruSystem 7500 and TruSystem 7000 U Surgical Tables

TruSystem surgical tables and operating table columns may drop unexpectedly, causing abrupt patient displacement during surgery.

Moderate risk, FDA, Device defect

Cochlear Nucleus Nexa Cochlear Implant with Contour Advance Electrode

Cochlear Nucleus Nexa cochlear implants have incomplete electrode welds, which can cause open circuits.

Moderate risk, FDA, Manufacturing problem

restor3d Veritas Reverse Total Shoulder Replacement

The Veritas Reverse Total Shoulder Replacement can dislocate, reduce range of motion, or lead to revision surgery.

Moderate risk, FDA, Device defect

Shimadzu Trinias Opera Smart, Opera Grand and Smart OBL Interventional Fluoroscopic X-Ray Systems

The mounting bolts securing the C-arm drive unit may not be torqued to specification.

Moderate risk, FDA, Device defect

Henry Schein Perma Sharp Surgical Sutures

Perma Sharp Sutures lack 510(k) clearance.

Moderate risk, FDA, Unapproved product

Halyard Minor Pack

Halyard Minor Pack may have open seals on header bags, compromising sterility.

Moderate risk, FDA, Sterility problem

Corin Unity Knee ASC Modular Handle

The Unity Knee ASC Modular Handle may malfunction, causing its locking mechanism to fail.

Moderate risk, FDA, Device defect

Baxter TruSystem 7000 U and 7500 U Operating Tables

TruSystem 7000 U Operating Table and Mobile column TruSystem 7500 U may drop unexpectedly, causing patient displacement and serious injury.

Moderate risk, FDA, Device defect

2 recalls that day

Edwards Lifesciences Commander M Delivery System

The Edwards Commander M Delivery System may have a manufacturing issue causing cardiovascular balloon rupturing.

High risk, FDA, Manufacturing problem

Cardinal Health Presource PBDS Kits with BD Alaris Pump Infusion Sets

Kits contain infusion sets which were recalled for performance issues.

High risk, FDA, Device defect

6 recalls that day

Artivion CryoPatch SynerGraft Pulmonary Human Cardiac Patch

The patch was implanted, and due to limitations of long-term in vivo data, the possibility of premature graft dysfunction cannot be excluded.

Moderate risk, FDA, Device defect

Illumina NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx Instruments

Illumina NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx Instruments have a cybersecurity vulnerability that may compromise data transmission.

Moderate risk, FDA, Software defect

Natus Embletta MPR PG Sleep Monitor

The Embletta MPR PG Multi Parameter Recorder Sleep Monitor may be unable to correctly format its internal memory.

Moderate risk, FDA, Device defect

Smith & Nephew EVOS Lateral Proximal Tibia Plate

A Partial Articular Lateral Proximal Tibia Plate implant was labeled and laser etched as a Lateral Proximal Tibia Plate.

Moderate risk, FDA, Labeling error

Accriva Diagnostics Hemochron Jr. APTT Test Cuvettes

The Hemochron Jr. APTT test cuvette may have a mispositioned or absent reagent, causing erroneous results and potential thrombosis.

Moderate risk, FDA, Device defect

Tandem Diabetes Care Tandem Mobi Insulin Pump

Tandem Mobi insulin pumps may generate false-positive occlusion alarms, suspending insulin delivery and potentially causing elevated blood glucose levels.

High risk, FDA, Device defect

3 recalls that day

ArjoHuntleigh Polska Sp. Z.O.O. Carevo Height-Adjustable Shower Trolley

The Carevo height-adjustable shower trolley can open unintentionally, leading to patient falls and serious injury.

Moderate risk, FDA, Device defect

Stryker Leibinger Precision Pointer Electromagnetic

The Precision Pointer Electromagnetic may fracture during use, and loose parts may fall out while inside the patient.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Nalu Neurostimulation System Therapy Disc and Patient Kit

The Therapy Disc has a firmware issue that causes it to attempt to restart, then fail, becoming non-functional.

Moderate risk, FDA, Software defect

2 recalls that day

Pentax Medical Ultrasound Endoscopes and Water Bottle Assembly

Warnings were added to the instructions for use for ultrasound endoscopes and water bottle assembly.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The controller may have an RFID firmware issue causing failure to recognize the purge cassette.

High risk, FDA, Software defect

4 recalls that day

Medtronic CareLink SmartSync Programmer, Patient Connector and Device Manager App

A software problem may cause an inaccurate displayed longevity estimate.

Moderate risk, FDA, Software defect

Philips Azurion 3, 5, and 7 Systems

Philips Azurion systems may have solid-state drives not specified in the Medical Device File, causing loss of imaging or access to images.

Moderate risk, FDA, Device defect

BioMerieux EMAG Nucleic Acid Sample Preparation Instrument

The EMAG system can delay or produce no results when analyzing clinical samples due to a software error.

Moderate risk, FDA, Software defect

Canon Medical System Alphenix Interventional Angiography Systems

The Alphenix interventional angiography system may experience an internal error due to a software issue.

Moderate risk, FDA, Software defect

1 recall that day

Philips North America Model 712010

The device can fail immediately after an exposure, causing the system to remain stationary.

Moderate risk, FDA, Device defect

3 recalls that day

Ziehm-Orthoscan VERSA Accessory Cart and Versa Mini C-Arm System

The Orthoscan VERSA Accessory Cart and Versa Mini C-Arm System have a weld that may fail, causing the monitor arm to separate.

Moderate risk, FDA, Device defect

Medtronic OmniaSecure Model 3930M Leads

The OmniaSecure Model 3930M lead may have difficulty achieving fixation during implantation, potentially causing tissue trauma.

Moderate risk, FDA, Device defect

Ethicon Ethilon Nylon Suture

Ethilon Nylon Suture may have needles with distorted curvature that may break during use, causing additional soft tissue or vessel injury.

Moderate risk, FDA, Device defect

10 recalls that day

Halyard Anterior Hip Packs

Halyard Anterior Hip Pack may contain a non-sterile component placed outside the sterile barrier.

Moderate risk, FDA, Sterility problem

Medline C-Section Drapes and Medical Convenience Kits

Medline drape and convenience kits are difficult to remove from patients and leave adhesive residue on skin.

Moderate risk, FDA, Device defect

Solstice Xact Mole Marker for Mammography

The Xact mole marker for mammography may have its radiopaque material detach, causing artifact in some cases.

Moderate risk, FDA, Device defect

Medtronic Neuromodulation InterStim SureScan MRI Leads and Percutaneous Extensions

InterStim SureScan MRI Leads may be used with the wrong lead or extension, preventing the system from working as intended.

Moderate risk, FDA, Device defect

Medtronic MiniMed Go App

The MiniMed Go app has a software defect that can cause missed or delayed insulin doses, potentially leading to hyperglycemia or hypoglycemia.

Moderate risk, FDA, Software defect

restor3d MTP Implants

The restor3d MTP Implant may not have been sterilized, as indicated by orange sterilization indicators.

Moderate risk, FDA, Device defect

CooperVision Softmed Breathables Advanced Toric Contact Lenses

The contact lens carton incorrectly states it is indicated for extended wear, but it is not approved for that use.

Moderate risk, FDA, Unapproved product

Boston Scientific Cork Direxion Torqueable Microcatheters

The Direxion Torqueable Microcatheter is defective due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

Moderate risk, FDA, Device defect

Life Technologies Ion Torrent Genexus Dx Integrated Sequencer

The Ion Torrent Genexus Dx with software has vulnerabilities in its DNA or RNA sequencing system software.

Moderate risk, FDA, Software defect

Techno-Path Multichem AE Unassayed Chemistry Controls

Techno-Path Multichem AE quality control material has a stability drift affecting the Ammonia analyte, which may delay results to physicians.

Moderate risk, FDA, Labeling error

3 recalls that day

Beckman Coulter Rotor SW40 and SW41

Beckman Coulter Rotor SW40 and SW41 may break into two or more pieces.

Moderate risk, FDA, Device defect

Medtronic MiniMed CareLink Clinic

CareLink Clinic software has a defect that can lead to incorrect insulin dosing.

Moderate risk, FDA, Software defect

VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator

The Vacuette blood collection tube may contain EDTA contamination, leading to falsely elevated potassium and falsely decreased calcium results.

Moderate risk, FDA, Contamination

1 recall that day

Ventec Life Systems VOCSN, V+Pro, VC and V*Home Ventilators

The ventilator's internal flow transducer cable connector may disconnect from the internal board.

High risk, FDA, Device defect

7 recalls that day

Philips Smart-Hopping 2.0 AP 1.4 GHz

Philips Smart-hopping 2.0 AP 1.4 GHz has unreliable wireless roaming behavior that can cause loss of connectivity to the central monitoring system.

Moderate risk, FDA, Device defect

Medtronic NDI Passive Spheres and Biopsy Needle Kit

Medtronic NDI Passive Spheres and Biopsy Needle Kit have variation in reflective material that may affect navigation tracking.

Moderate risk, FDA, Device defect