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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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7 recalls that day

B Braun SAFSITE Injection Site

The product has a potential for leakage and backflow at the Safsite valve.

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 square driver failed to meet design specifications.

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 that day

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 their steam sterilization instructions have been updated.

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, potentially causing increased procedural time and inadequate treatment.

Moderate risk, FDA, Device defect

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

DxU 840m Iris, DxU 850m Iris and IQ200 Sprint may leak lamina fluid onto the table or floor if a check valve is not replaced annually.

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 may give inaccurate results, requiring changes to instructions for use.

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 that may delay patient PTH results.

Moderate risk, FDA, Device defect

4 recalls that day

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 liquid may escape when opened.

Moderate risk, FDA, Device defect

Ethicon PERMA-HAND Silk Surgical Suture

Silk sutures packaged with alcohol-based fluid may cause surgical delay if discovered before use.

Moderate risk, FDA, Device defect

2 recalls that day

Baxter Likorall Overhead Lifts

Likorall Overhead Lifts may lower the lift strap more quickly than expected, posing a risk of injury from a fall.

Moderate risk, FDA, Device defect

BioFire FilmArray Pneumonia and Joint Infection Panels

The FilmArray Pneumonia Panel, Pneumonia Panel plus, and BioFire Joint Infection Panel may give false positive results due to contamination.

Moderate risk, FDA, Device defect

1 recall that day

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

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 that day

Integrated Medcraft FORWARD Gunshot Wound Kit

The Forward Gunshot Wound Kit has a sterile pad that may degrade over time, potentially dislodging remnants on the 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 failed testing.

Moderate risk, FDA, Sterility problem

Ferno-Washington Power F2 Powered Fastening System

Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher.

Moderate risk, FDA, Software defect

Sarnova HC Curaplex Capnography Oral Nasal Cannula Multipack

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

Moderate risk, FDA, Device defect

Boston Scientific NaviFlex LW Pusher and Advx Panc Stent

The NaviFlex LW Pusher; Advx Panc. Stent 4/5F was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port).

Moderate risk, FDA, Device defect

Neuronetics NeuroStar Advanced Therapy Systems

The cables in the NeuroStar Advanced Therapy System are not in conformance with the product specifications required in the production of the HP Coil Assembly.

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

Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312

Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312 may have quality control failures with Klebsiella pneumoniae when using a certain feature.

Moderate risk, FDA, Device defect

Medtronic Sofamor Danek Grafton DBM and Grafton Plus DBM Bone Grafts

Grafton DBM and Grafton Plus DBM may cause infection if implanted.

Moderate risk, FDA, Contamination

JenaValve Trilogy Delivery Catheters

The Jenavalve Trilogy Delivery Catheter may have sleeve liner separation, causing difficulty or inability to deploy the heart valve device.

Moderate risk, FDA, Device defect

7 recalls that day

Steris HexaVue Focus Integration System

HexaVue Focus Integration System may mismatch patient information on printed images, causing documentation discrepancies.

Moderate risk, FDA, Software defect

LeMaitre Vascular TufTex Over-the-Wire Embolectomy Catheter

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Moderate risk, FDA, Device defect

Mindray DS Patient Monitors and Telemetry Monitoring Systems

Mindray DS Patient Monitors and Telemetry Monitoring Systems may have insufficient descriptions of alarm functions.

Low risk, FDA, Device defect

Intellijoint Navigation System and Intellijoint HIP Systems

The Intellijoint Navigation System has a workstation that may contain a MacBook Pro battery that may overheat and pose a fire safety risk.

Moderate risk, FDA, Device defect

Canon Medical Alphenix INFX-8000C/B5

The Alphenix INFX-8000C/B5 has loosening bolts that may cause tabletop shift and misalignment.

Moderate risk, FDA, Device defect

Polymedco Sediplast

Sediplast tubes may cause increased resistance when inserting the pipette, leading to cap detachment and potential blood exposure.

Moderate risk, FDA, Device defect

AVID Medical Custom Surgical Procedure Kits

AVID Medical Custom Surgical Procedure Kits may be contaminated with a lubricant used during manufacturing.

Moderate risk, FDA, Contamination

2 recalls that day

Onkos Surgical My3D Personalized Pelvic Implant

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Moderate risk, FDA, Device defect

Nihon Kohden CNS-6200 Series Central Nurse Station

The central nurse station has a cybersecurity issue that could disrupt monitoring of multiple beds and alarm visualization.

Moderate risk, FDA, Software defect

3 recalls that day

Medtronic MiniMed Flex Insulin Pumps

The MiniMed Flex insulin pump may have failed verification tests, causing issues like inaccurate insulin delivery.

Moderate risk, FDA, Device defect

Medline Bariatric Steel Rollators

The rollator's front fork stem bolt/wheel assembly may disconnect, causing the front wheels to detach and risk severe falls.

Moderate risk, FDA, Device defect

Stryker Sustainability Solutions Bard EP XT Decapolar Steerable Diagnostic EP Catheter

The diagnostic EP catheter may have a breached sterile barrier, which could lead to particulate embolization, infection, or thrombus.

Moderate risk, FDA, Sterility problem

10 recalls that day

Safeguard US Operating Battle Bandage

The compression bandage may be degraded, which may cause unwanted foreign material inside the wound, leading to infection.

Moderate risk, FDA, Foreign object

HALYARD Laparoscopy Comprehensive Pack II

Laparoscopy packs labeled as latex free contain a latex urethral catheter.

Moderate risk, FDA, Labeling error

Glypto Device, Glypto Cryo Machine

The Glypto Device and Glypto Cryo Machine lack 510(k) clearance.

Moderate risk, FDA, Unapproved product

Presource Packs Containing Medtronic Microstream Components

Presource Packs containing Medtronic Microstream Components may cause delay to treatment and unintended extubation.

Moderate risk, FDA, Device defect