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Medical device recalls

Medical device recalls from FDA, newest first.
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6 recalls

GSP Neonatal GALT Kit

The GSP Neonatal GALT Kit may have a stability issue that can delay patient results.

Moderate risk, FDA, Device defect

Elekta Brachytherapy Applicators

The Fletcher CT/MR Shielded Applicator Set can detach its intrauterine tube tip, which may remain within a patient.

Moderate risk, FDA, Device defect

7 recalls

KL Owen Custom Orthodontic Solution

The orthodontic solution has a product error defect that may cause incorrect bracket placement.

Moderate risk, FDA, Device defect

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

The assay has a potential for intermittent well-to-well bias.

Moderate risk, FDA, Device defect

MiniMed 780G Insulin Pump

The MiniMed 780G Insulin Pump can stop delivering insulin due to a software anomaly, leading to delayed therapy and increased risk of hyperglycemia or DKA.

Moderate risk, FDA, Software defect

Medline Convenience Kits

Medline Convenience Kits contain temperature probes with an error in their distribution control process.

Moderate risk, FDA, Device defect

Fresenius Medical Care 5008X Blood Tubing Sets

5008X Blood Tubing Set may have connection issues that can cause online port errors.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Intracept Access Instruments

Intracept Access Instruments may have a sterile barrier breach, which could lead to severe infection.

Moderate risk, FDA, Sterility problem

Encore Medical EMPOWR 3D Knee Implants

The knee device has a packaging discrepancy with incorrect product size mixed up.

Moderate risk, FDA, Packaging defect

2 recalls

ConvaTec Aquacel Ag Surgical SP

Surgical dressing manufactured out of specification (greater thickness).

Moderate risk, FDA, Quality testing problem

Olympus Single Use Distal Cover

The Olympus Single Use Distal Cover has a newly designed replacement version.

Moderate risk, FDA, Device defect

9 recalls

Zimmer Biomet A.T.S. 4000 TS Tourniquet System Sterile Hoses

Sterile tourniquet hoses may have a sterility breach, potentially causing moderate localized infection.

Moderate risk, FDA, Sterility problem

GORE TAG Thoracic Branch Endoprosthesis Side Branch Component

The GORE TAG Thoracic Branch Endoprosthesis Side Branch Component can separate from its catheter.

Moderate risk, FDA, Device defect

Medline Reprocessed Electrophysiology and Ultrasound Catheters

Reprocessed electrophysiology catheters may contain small particles of residual material, posing a risk of inflammatory response or infection.

High risk, FDA, Foreign object

Bard Catheters, Dialysis Catheters, and Biopsy Trays

The lidocaine ampoules in these devices were manufactured under deficient practices and are being recalled by the supplier.

Moderate risk, FDA, Manufacturing problem

BD Medline 111 Gravity Set

The gravity set was shipped as an engineering sample labeled not for human use.

Moderate risk, FDA, Unapproved product

Medtronic Harmony Delivery Catheter System

The Medtronic Harmony Delivery Catheter System may have an increased potential for distal tip detachment under certain conditions.

High risk, FDA, Manufacturing problem

Solar GI System (Water Perfusion)

The Solar GI System can accumulate moisture inside its tubing or sensors, affecting airflow or pressure measurement.

Moderate risk, FDA, Device defect

Covidien Shiley Disposable Decannulation Plug

The Covidien Shiley Disposable Decannulation Plug has incorrect labeling that includes a symbol for non-DEHP, but the product contains DEHP.

Moderate risk, FDA, Labeling error

Masimo Radius VSM ECG Sets and NIBP Cuffs

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

Moderate risk, FDA, Device defect

12 recalls

Zeiss Intrabeam Spherical Applicator 1.5 cm

The Zeiss Intrabeam Spherical Applicator 1.5 cm 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

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

High risk, FDA, Contamination

RaySearch RayCare Oncology Information Systems

Beam set delivery note issues can cause data loss if the note is modified simultaneously or 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 of Volara system patient circuits.

High risk, FDA, Device defect

Medela ENFit Enteral Extension Sets

The ENFit ExSet Strl 60 2.0ml PV 1ct EN may have incorrect connectors, causing misconnection and delivery delays.

Moderate risk, FDA, Device defect

Siemens ARTIS Icono Biplane, Ceiling and Floor

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

The Cyberknife system's collimator may not fully dock, triggering an interlock and preventing motion.

Moderate risk, FDA, Device defect

Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators

Potential sterile breach of the pouches in which devices are packaged.

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

Pilling Wecksorb Neurosponges and Neurosponge Strips may have 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 and move during patient positioning.

Moderate risk, FDA, Device defect

2 recalls

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

Medline Convenience Kits

Medline Convenience Kits contain lidocaine ampules with quality issues that may affect their use.

Moderate risk, FDA, Device defect

Depuy Synthes Attune Revision Hinge Knee Components

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

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

Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

Medline Convenience kits contain Swan-Ganz catheters with leaks or breakage that may lead to 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

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 10mL polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

Abiomed Impella CP Sets and Low Profile Introducer Kits

Potential for thrombus formation during prolonged use of the introducer.

High risk, FDA, Device defect

8 recalls

Philips Telemetry Monitor 5500 1.4 GHz

The Philips Telemetry Monitor 5500 1.4 GHz 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.

High risk, FDA, Device defect

GE Healthcare AW Server 3.2 ext.6.5

The AW Server may open the previous patient's exam instead of the intended one, potentially leading to misdiagnosis.

Moderate risk, FDA, Device defect

Octopus 4, Evolution, and Evolution AS Tissue Stabilizer

The Octopus Evolution Tissue Stabilizer has an assembly issue where 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 be unable to detach a coil.

Moderate risk, FDA, Device defect