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Medical device recalls

Medical device recalls from FDA, newest first.
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3 recalls

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

The accessory cart and 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

Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation.

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

AVID Medical Halyard Anterior Hip Packs

The 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 C-Section Drapes and Medical Convenience Kits are difficult to remove from the patient and leave adhesive residue on the patient's 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 artifacts.

Moderate risk, FDA, Device defect

Medtronic InterStim SureScan MRI Leads and Percutaneous Extensions

Wrong lead or percutaneous extension selected.

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 shown by orange sterilization indicators.

Moderate risk, FDA, Device defect

CooperVision Softmed Breathables Advanced Toric Contact Lenses

The contact lens is labeled for extended wear but is intended for daily wear only.

Moderate risk, FDA, Unapproved product

Boston Scientific 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 the physician.

Moderate risk, FDA, Labeling error

3 recalls

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 CareLink Clinic

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

Moderate risk, FDA, Software defect

VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator

Blood collection tubes may contain EDTA contamination, leading to falsely elevated potassium and decreased calcium results.

Moderate risk, FDA, Contamination

1 recall

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

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

B Braun SAFSITE Injection Site

The B Braun Safsite Injection Site has a potential for leakage and backflow.

Moderate risk, FDA, Device defect

Philips Lumify Diagnostic Ultrasound System

The Philips Lumify Diagnostic Ultrasound System may not recognize transducer registration, prevent scanning, or have unstable connections.

High risk, FDA, Device defect

Think Surgical Square Driver

The Think Surgical Square Driver failed design specifications, potentially causing a pin to stick or wobble during drilling.

Moderate risk, FDA, Quality testing problem

Abbott Amplatzer Amulet Left Atrial Appendage Occluder

The Amplatzer Amulet Left Atrial Appendage Occluder has changes to its instructions regarding risk of pulmonary artery injury.

Moderate risk, FDA, Device defect

Axonics PNE Lead Implant Kit

The PNE Lead Implant Kit may leak, break, or experience other issues that may pose a risk to users.

Moderate risk, FDA, Device defect

12 recalls

Medline Foot Ankle Convenience Kit

The Medline convenience kit labeled Foot Ankle has a discrepancy in the shelf-life of a component.

Moderate risk, FDA, Device defect

Healthmark Vinyl Instrument Guards

Vinyl Instrument Guards have labeling that is not compliant with regulations and updated sterilization instructions.

Moderate risk, FDA, Labeling error

Merit Medical Systems Scout MD Delivery System

The Scout MD Delivery System may have difficulty deploying, which could prevent the reflector from functioning.

Moderate risk, FDA, Device defect

Intelerad IntelePACS and InteleConnect Portal Radiological Image Processing Systems

IntelePACS and InteleConnect Portal/Tech Portal may show report and displayed images that do not match.

Moderate risk, FDA, Device defect

Medline Convenience Kits Containing CONMED AirSeal Access Ports

Convenience Kits containing Conmed AirSeal Access Ports may cause delays or ending procedures due to erroneous overpressure alerts and system venting.

Moderate risk, FDA, Device defect

Medline Surgical Convenience Kits

Medline surgical convenience kits contain cannula components that may leak or break during use.

Moderate risk, FDA, Device defect

Howmedica Osteonics Triathlon Hinge Femoral Prep, Femoral Prep, Misc. Instruments and Universal Baseplate Finishing Trays

The reprocessing instructions specify a 30-minute dry time for trays sterilized in blue wrap.

Moderate risk, FDA, Device defect

Cook Williams Cystoscopic Injection Needles

Williams Cystoscopic Injection Needles may have a misaligned Luer lock adapter, increasing procedural time and causing inadequate treatment.

Moderate risk, FDA, Device defect

Beckman Coulter DxU 840m Iris, DxU 850m Iris, IQ200 Sprint Analyzers

The DxU 840m Iris, DxU 850m Iris, IQ200 Sprint, IQ200 Select, and IQ200 Elite may leak lamina fluid, posing slip, chemical.

Moderate risk, FDA, Device defect

Magellan Diagnostics LeadCare II Blood Lead Test Kit

The LeadCare II Blood Lead Test Kit may show a wrong expiration date, causing an error and delayed results.

Low risk, FDA, Labeling error

Radiometer Medical ABL90 FLEX and ABL90 FLEX PLUS Analyzers

The ABL90 Flex and ABL90 Flex Plus analyzers have a risk of potentially inaccurate results.

Moderate risk, FDA, Device defect

Microgenics MAS Omni IMMUNE PRO Immunoassay Controls

MAS Omni Immune Pro Liquid Assayed Integrated Immunoassay Control has vial-to-vial variability causing low PTH recovery, which may delay patient PTH results.

Moderate risk, FDA, Device defect

4 recalls

Gore Viabil Short Wire Biliary Endoprosthesis

The Gore Viabil Short Wire Biliary Endoprosthesis may be mislabeled with the incorrect length.

Moderate risk, FDA, Labeling error

In2bones CoLag Screw FT

Bone screws labeled as fully threaded are actually partially threaded.

Moderate risk, FDA, Labeling error

Steris Rapicide PA Part A High-Level Disinfectant

Rapicide PA Part A High-Level Disinfectant may swell if its vented cap is blocked, and could expose users to vapor or liquid.

Moderate risk, FDA, Device defect

Ethicon PERMA-HAND Silk Surgical Suture

PERMA-HAND Silk surgical sutures may contain alcohol-based fluid, causing surgical delay or tissue irritation.

Moderate risk, FDA, Device defect

2 recalls

Baxter Likorall Overhead Lifts

Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.

Moderate risk, FDA, Device defect

BioFire FilmArray Pneumonia and Joint Infection Panels

BioFire Diagnostics is recalling 3 products.

Moderate risk, FDA, Device defect

1 recall

Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)

The HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.

High risk, FDA, Device defect

10 recalls

Integrated Medcraft FORWARD Gunshot Wound Kit

The Forward Gunshot Wound Kit has a sterile pad that may degrade over time, potentially causing pad remnants to dislodge near a wound.

Moderate risk, FDA, Device defect

SI-BONE iFuse TORQ Implant System

The iFuse TORQ Implant System may not be sterile because its packaging seal integrity was not assured.

Moderate risk, FDA, Sterility problem

Ferno-Washington Power F2 Powered Fastening System

The Power F2 Powered Fastening System may have intermittent loss of powered function, causing reduced performance or delays in patient transport.

Moderate risk, FDA, Software defect

Sarnova Curaplex Capnography Oral Nasal Cannula Multipack

The Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack contains pediatric nasal cannulas instead of adult ones.

Moderate risk, FDA, Device defect

Boston Scientific NaviFlex LW Pusher and Advx Panc Stent

The device was incorrectly manufactured with a guidewire exit port, which is not a design feature.

Moderate risk, FDA, Device defect

Neuronetics NeuroStar Advanced Therapy Systems

The NeuroStar Advanced Therapy System has cables that are not in conformance with product specifications.

Moderate risk, FDA, Device defect

Cadwell IOMAX Cortical Module

The IOMAX Cortical Module may unintentionally deliver electrical stimulation or allow unintended current to reach the patient.

Moderate risk, FDA, Device defect