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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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9 recalls that day

Masimo Radius VSM ECG Sets and NIBP Cuffs

Radius VSM ECG pre-connected Set and Radius VSM Disposable NIBP Cuff may have issues that could delay treatment or cause skin irritation.

Moderate risk, FDA, Device defect

12 recalls that day

Zeiss Intrabeam Spherical Applicator 1.5 cm

The spherical applicator, a radiation therapy accessory, failed to meet manufacturing specifications.

Moderate risk, FDA, Quality testing problem

Siemens ARTIS Icono Ceiling

The ARTIS icono ceiling has a potential issue with the suspension that holds the monitor, and screws may loosen over time.

Moderate risk, FDA, Device defect

Aligned Medical Solutions Surgical Convenience Kits

Surgical convenience kits contain alcohol prep pads that may be contaminated.

High risk, FDA, Contamination

RaySearch RayCare Oncology Information Systems

Beam set delivery notes in RayCare have potential data loss when a note is updated during a treatment session.

Moderate risk, FDA, Device defect

Hillrom Volara Circuit Kits

There have been reports of air and medication leakage from the nebulizer cup during therapy.

High risk, FDA, Device defect

Medela ENFit Enteral Extension Sets

ENFit ExSet Strl 60 may contain incorrect connectors and will not attach or misconnect to ENFit connections.

Moderate risk, FDA, Device defect

Siemens ARTIS Icono Biplane, Ceiling and Floor

The product may have potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Moderate risk, FDA, Device defect

Accuray CyberKnife Treatment Delivery System and Linear Accelerator

A collimator may not fully dock, triggering an interlock and preventing motion from the console.

Moderate risk, FDA, Device defect

Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators

CRE Pro Wireguided and CRE Wireguided devices may have a sterile breach of their pouches.

Moderate risk, FDA, Sterility problem

Hamilton Medical IntelliCuff Portable Automatic Cuff Pressure Controller

The IntelliCuff portable automatic cuff pressure controller may alarm with a leakage error and fail to maintain pressure.

Moderate risk, FDA, Device defect

Pilling Wecksorb Neurosponges and Neurosponge Strips

The product has out-of-specification levels of endotoxins.

Moderate risk, FDA, Quality testing problem

Baxter Adapter for Head Positioning

The Adapter for Head Positioning may become loose during patient positioning and move.

Moderate risk, FDA, Device defect

2 recalls that day

Remel GC Agar Base

GC Agar Base may have reduced or no recovery of some strains of Neisseria gonorrhoeae.

Moderate risk, FDA, Device defect

Hamilton Medical Coaxial Breathing Circuit Sets

The coaxial breathing circuit may have expiratory valve membranes sticking, causing an exhalation obstructed alarm and inadequate ventilation.

High risk, FDA, Device defect

3 recalls that day

Medline Convenience Kits

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM).

Moderate risk, FDA, Device defect, FDA event number 99162

Depuy Synthes Attune Revision Hinge Knee Components

The external sterile packaging was found adhered to the internal sterile packaging.

Moderate risk, FDA, Sterility problem

Medacta Short Monobloc Stem Broaches

Short Monobloc Stem Broaches may increase the risk of fracture in the medial region of the proximal humerus.

Moderate risk, FDA, Device defect

2 recalls that day

Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

Medline Convenience kits contain Swan-Ganz catheters with a hub that may leak, causing infection, medication loss, or blood loss.

Moderate risk, FDA, Device defect

Mentor Texas Syringes

Expired syringes were distributed due to a distribution system control failure.

Moderate risk, FDA, Device defect

3 recalls that day

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump

The Intera Oncology Intera 3000 Hepatic Artery Infusion Pump has potential for leakage along the drug pathway.

Moderate risk, FDA, Device defect

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Convenience kits with polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

Abiomed Impella CP Sets and Low Profile Introducer Kits

Abiomed Impella CP Sets and Low Profile Introducer Kits have potential for thrombus formation during prolonged use of the introducer.

High risk, FDA, Device defect

8 recalls that day

Philips Telemetry Monitor 5500 1.4 GHz

The telemetry monitor may reset to a default state, causing loss of configuration and failure to reconnect.

Moderate risk, FDA, Labeling error

Persona Revision Trabecular Metal Femoral Distal Augment

The Persona Revision Trabecular Metal Femoral Distal Augment may contain a posterior augment inside its package.

Moderate risk, FDA, Device defect

Thuvera Laser Console

The Thuvera Laser Console has a software anomaly that causes a false display of error code 5018.

Moderate risk, FDA, Software defect

Medline Convenience Kits

Medline Convenience Kits contain Lidocaine and Bupivacaine injections with quality issues identified during an FDA inspection of the supplier.

High risk, FDA, Device defect, FDA event number 99043

GE Healthcare AW Server 3.2 ext.6.5

GE Healthcare AW Server 3.2 ext.6.5 may open the previous patient's exam instead of the intended one, leading to misdiagnosis.

Moderate risk, FDA, Device defect

Octopus 4, Evolution, and Evolution AS Tissue Stabilizer

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.

Moderate risk, FDA, Manufacturing problem

Surgify Halo Surgical Drills and Burrs

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Moderate risk, FDA, Device defect

Stryker Neurovascular Inzone Detachment System

The Inzone Detachment System may experience premature battery drain, causing it to not power on or detach a coil as intended.

Moderate risk, FDA, Device defect

4 recalls that day

Acumed Hexalobe Screws

Hexalobe screws used with wrist fixation system may break during use.

Moderate risk, FDA, Manufacturing problem

Zimmer Off-Axis Comprehensive Shoulder System Reamer Guides

The plastic guides were catching during reaming, leading to breakage.

Moderate risk, FDA, Device defect

PFM Medical Multi-Snare Sets

The Multi-Snare Set failed to meet biocompatibility requirements, which could cause localized inflammation and tissue irritation.

Moderate risk, FDA, Device defect

Ventec Life Systems VOCSN+Pro Package

The VOCSN+Pro respiratory system may have a damaged back-up battery, causing the backup alarm not to activate during power loss.

Moderate risk, FDA, Device defect

3 recalls that day

Philips Avalon Fetal Monitor

Philips Avalon Fetal Monitor has incorrect speaker connector assembly that can cause loss of speaker output.

Moderate risk, FDA, Device defect

Intuitive Surgical Da Vinci PSS SP1098

Da Vinci surgical system components may have a pin issue that can cause uncontrolled motion.

Moderate risk, FDA, Device defect

TMJ Solutions Bilateral Implants

Custom temporomandibular joint implant may have contained incorrect patient-specific components, leading to a poor fit and a right-sided open bite.

Moderate risk, FDA, Device defect

8 recalls that day

Datex-Ohmeda Giraffe and Panda Infant Resuscitation Systems

Blender knob shaft can loosen, which can affect the delivered oxygen concentration.

High risk, FDA, Device defect

HeartMate 3 Left Ventricular Assist System Kits, System Controller, and Backup Battery

The products may fail due to 11 volt Backup Battery failures.

Moderate risk, FDA, Device defect

STAAR ICL Calculation Software

The Staar ICL Calculation Software has a coding issue that affects the implant orientation diagram for toric lenses.

Moderate risk, FDA, Software defect

Inspire Respiratory Sensing and Stimulation Lead

The Inspire Respiratory Sensing Lead is labeled with an incorrect Use By Date, which may lead to premature revision surgery.

Moderate risk, FDA, Labeling error

Impella CP Set with SmartAssist

Impella CP Set with SmartAssist may cause low purge pressure alarms and interruption of circulatory support.

High risk, FDA, Device defect

BD Connecta Stopcocks

BD Connecta BD Luer-Lok 360 Stopcocks may have an unstable connection at Port C when used with a plastic luer-lok syringe.

Moderate risk, FDA, Device defect

Merit Medical Systems Splashwire Hydrophilic Guide Wire

The Splashwire Hydrophilic Guide Wire has unsealed portions of pouches.

Moderate risk, FDA, Packaging defect

Beta Bionics iLet Bionic Pancreas

This can lead to hyperglycemia.

Moderate risk, FDA, Software defect

5 recalls that day

Howmedica Osteonics Tri TS Baseplate

Triathlon Universal Baseplate Size 3 and Size 4 are in packaging labeled with the other size.

Moderate risk, FDA, Labeling error

Medline Urethral Catheters and Procedure Kits

Medline Industries is recalling 30 products.

Moderate risk, FDA, Quality testing problem

GE HealthCare Giraffe OmniBed Devices

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.

Moderate risk, FDA, Device defect

ConMed AirSeal Access Ports and Obturators

ConMed AirSeal Access Ports and Obturators have a potential for overpressure alerts.

Moderate risk, FDA, Device defect