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Medical device recalls

Medical device recalls from FDA, newest first.
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5 recalls

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

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

Moderate risk, FDA, Device 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

6 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

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

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

9 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

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

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

1 recall

Medline Convenience Kits

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

Moderate risk, FDA, Device defect

1 recall

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Convenience kits with 10mL polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

5 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

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

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

1 recall

Zimmer Off-Axis Comprehensive Shoulder System Reamer Guides

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Moderate risk, FDA, Device defect

2 recalls

Philips Avalon Fetal Monitor

The 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

The Da Vinci Assy, PSS, SP1098 may have a retainer pin issue that can cause uncontrolled motion.

Moderate risk, FDA, Device defect

6 recalls

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

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 printout.

Moderate risk, FDA, Software defect

Inspire Respiratory Sensing and Stimulation Lead

The Inspire Respiratory Sensing Lead has an incorrect Use By Date, which may lead to unplanned revision surgery.

Moderate risk, FDA, Labeling error

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

Howmedica Osteonics Tri TS Baseplate

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

Moderate risk, FDA, Labeling error

Medline Urethral Catheters and Procedure Kits

Medline urethral catheters and kits may have surface irregularities or connector issues.

Moderate risk, FDA, Quality testing problem

GE HealthCare Giraffe OmniBed Devices

The Giraffe OmniBed has a potential issue with the canopy soffit that could cause patient injury.

Moderate risk, FDA, Device defect

ConMed AirSeal Access Ports and Obturators

ConMed AirSeal Access Port and Obturator may cause overpressure alerts.

Moderate risk, FDA, Device defect

Mito Red Light Super Mobile

The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

Moderate risk, FDA, Device defect

1 recall

DirectCHECK ACT-LR Whole Blood Quality Control, Level 2

The whole blood quality control has labeling with an incorrect performance range.

Moderate risk, FDA, Labeling error

3 recalls

Medtronic O-Arm O2 Imaging System

The O-arm O2 Imaging System may show image artifacts due to a detector panel firmware anomaly.

Moderate risk, FDA, Software defect

ALYON and HarmonyAIR A-Series Surgical Lighting System

The surgical lighting system has light intensity control buttons that may detach.

Moderate risk, FDA, Device defect

HarmonyAIR A-Series Surgical Lighting System

The HarmonyAIR A-Series Surgical Lighting System has paint that may chip or peel on its light heads.

Moderate risk, FDA, Device defect

1 recall

Arrow International Vascular Access and Catheterization Kits

Paracentesis kits contain lidocaine, bupivacaine.

High risk, FDA, Sterility problem