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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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16 recalls that day

Halyard LAVH Packs

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Moderate risk, FDA, Device defect

Getinge Y Sensor Module, Servo-U, Servo-N

The Y sensor module for SERVO-U/-N ventilators did not undergo electrical safety and functional tests during production.

Moderate risk, FDA, Device defect

Boston Scientific OverStitch Suture Cinch and Suture Cinch Long

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Moderate risk, FDA, Device defect

Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device

TD Navio Midi and Maxi Speech Generating Devices may have damaged battery mounting tabs, causing internal short circuit and heating.

Moderate risk, FDA, Device defect

Arrowhead DE Arrow-LOK Implant

The Arrow-LOK Implant did not undergo required gamma radiation dose audit, which could lead to patient infection.

Moderate risk, FDA, Sterility problem

Kico Knee Innovation Arvis Surgical Navigation System GEN 2

The ARVIS surgical navigation system may show a tilted image due to an internal sensor issue.

Moderate risk, FDA, Device defect

Philips Cardiac Workstation 5000 and 7000

Philips Cardiac Workstation 5000 and 7000 may intermittently provide inaccurate heart rate data.

Moderate risk, FDA, Device defect

Dentsply Sirona Capsule Mixer

The Dentsply Sirona Capsule Mixer can discharge electricity when unplugged.

Moderate risk, FDA, Device defect

Intersurgical Guedel Oropharyngeal Airways

The One-Piece Guedel Airway could be occluded or partially occluded.

Moderate risk, FDA, Device defect

Foundation Medicine Hamilton Microlab STAR Liquid Handler

The Hamilton Microlab STAR Liquid Handler has a software issue that can cause increased spontaneous software closures.

Moderate risk, FDA, Software defect

EndoFLIP System

The EndoFLIP System can incorrectly flag catheters as expired, making them unavailable for clinical procedures.

Moderate risk, FDA, Device defect

2 recalls that day

Cardinal Health Presource Kits

Procedure kits contain neurological sponges with unexpected variability in endotoxin levels.

Moderate risk, FDA, Contamination

BD Intravascular Administration and Extension Sets

Intravascular administration sets may not have been sterilized correctly.

Moderate risk, FDA, Sterility problem

3 recalls that day

Erbe USA ERBECRYO 2 Cryosurgical Unit

The Erbecryo 2 Cryosurgical Unit can rupture due to excessive pressure from a pneumatic short circuit.

Moderate risk, FDA, Device defect

ProNephro AKI (NGAL) Reagent Kit

The ProNephro AKI (NGAL) Reagent Kit may lead to missed diagnosis of renal disease.

Moderate risk, FDA, Device defect

BIOFIRE Respiratory Panel 2.1 (RP2.1)

The Biofire Respiratory Panel 2.1 may give false negative results.

Moderate risk, FDA, Device defect

4 recalls that day

Straumann Bone Level Tapered (BLT) Implant

The Bone Level Tapered Implant may contain implants that are 12mm in length instead of 14mm as labeled.

Moderate risk, FDA, Labeling error

Waldemar Link Endo-Model Tibial Plateau Replacement Sets

The Endo-Model replacement set for a tibial plateau incorrectly contains a Pure Hinge plateau, which could lead to prolonged surgery or implant wear.

Moderate risk, FDA, Device defect

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter can have air bubbles in the drip chamber and tubing.

High risk, FDA, Device defect

Spectra Medical Devices Sodium Chloride Injection

Sodium Chloride Injection may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.

High risk, FDA, Sterility problem

6 recalls that day

OBP Medical ER-Spec Single-Use Vaginal Speculum with LED Light Source

The ER-Spec Single-Use Vaginal Speculum may have a sharp edge on its blade.

Moderate risk, FDA, Device defect

Philips Azurion

Philips Azurion x-ray system has software issues that may delay therapy and cause complications.

Moderate risk, FDA, Software defect

Philips Azurion Interventional Fluoroscopic X-Ray Systems

Philips Azurion Rystem has software issues that may delay therapy and cause procedural complications.

Moderate risk, FDA, Software defect

Straumann GM Helix Dental Implants

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.

Moderate risk, FDA, Labeling error

Philips Allura Xper FD Interventional Fluoroscopic X-Ray Systems

Allura Xper FD has a firmware issue that could lead to loss of geometry movements.

Moderate risk, FDA, Software defect

Terumo Glidesheath Slender A-Kit

The Glidesheath Slender was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Moderate risk, FDA, Device defect

8 recalls that day

Thermo Fisher Diagnostics Neisseria Meningitidis Gp C Tests

Certain lots of Neisseria meningitidis Gp C 2ml/VL are not performing to criteria.

Moderate risk, FDA, Quality testing problem

Medline Micro-Kill Bleach Germicidal Bleach Wipes

Medline Micro-Kill Bleach Germicidal Bleach Wipes may have reduced bleach concentration, compromising disinfection and allowing pathogen survival.

Moderate risk, FDA, Contamination

Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices

Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices may contain a perforation or tear in the sterile barrier packaging.

Moderate risk, FDA, Sterility problem

Galt Medical Boston Scientific Enhance Transcarotid/Peripheral Access Kit

The Enhance Transcarotid/Peripheral Access Kit has black depth markings that may detach from the outer sheath.

Moderate risk, FDA, Device defect

Xhibit Central Station

The Xhibit Central Station has audio/video failures due to an off-the-shelf display port component.

Moderate risk, FDA, Device defect

GORE VIABIL Short Wire Biliary Endoprosthesis

A biliary endoprosthesis is incorrectly labeled, with a 10 mm x 7 cm device labeled as a 10 mm x 10 cm device.

Moderate risk, FDA, Labeling error

Roche Navify Digital Pathology Software

The navify Digital Pathology Image Management System may show a discrepancy between an image and its metadata in the Viewer window.

Moderate risk, FDA, Device defect

BOBBY Balloon Guide Catheter

The BOBBY Balloon Guide Catheter has an increased rate of balloon pinhole defects.

Moderate risk, FDA, Device defect

5 recalls that day

Contego Medical Neuroguard IEP Carotid Stent and Balloon System

The Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System may fail to open its integrated filter.

Moderate risk, FDA, Device defect

TISSIUM COAPTIUM Connect Peripheral Nerve Repair Devices

Currently labeled shelf life of 36 months is not substantiated by real-time data.

Moderate risk, FDA, Labeling error

Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis

The Blom-Singer Classic Indwelling Voice Prosthesis has incorrect labeling.

Moderate risk, FDA, Labeling error

Instrumentation Laboratory GEM Premier 7000 and GEM Premier 5000 Blood Analyzers

The lysing bag solution of specific GEM Premier 7000 and GEM Premier 5000 lots did not have the established active ingredient concentration.

Moderate risk, FDA, Device defect

U2 Total Knee System Femoral Offset Bushings

The U2 Total Knee System femoral offset bushing has incorrect engraved numbering that could cause incorrect orientation of the implant.

Moderate risk, FDA, Device defect

8 recalls that day

Medline Hudson RCI Heated Neonatal Breathing Circuits

Neonatal and infant heated wire breathing circuits may fail sporadically.

Moderate risk, FDA, Device defect

Siemens Healthcare Diagnostics Atellica CH Urine Albumin

Atellica CH Urine Albumin tests may give falsely depressed results for other tests and cause delays.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan LabPro Panel Update Software

MicroScan LabPro V5.03 Panel Update 11 has incorrect algorithms that may affect antimicrobial susceptibility test results.

Moderate risk, FDA, Software defect

Aniara Diagnostica 5-PLASMA Bivalirudin Kits, Calibrators and Controls

The 5-Plasma Bivalirudin AMR Verification Kit, Calibrator, and Control have stability issues that degrade measurable bivalirudin.

Moderate risk, FDA, Quality testing problem

Philips Allura and Azurion X-Ray Systems

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Moderate risk, FDA, Device defect

HardyDisk AST Cefiderocol 30µg (FDC30)

HardyDisk AST Cefiderocol disks may give false-susceptible or false-resistant results in susceptibility testing, including of Pseudomonas aeruginosa.

Moderate risk, FDA, Device defect

United Orthopedic U2 and USTAR II Knee Trial and Instrument Sets

Knee prosthesis trials and adaptors may not assemble properly due to an incomplete process of the component screw.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Infinion CX Lead Kit

The Infinion CX lead kit may be exposed to stress at the anchor site, causing high impedance or lead fractures.

High risk, FDA, Device defect

7 recalls that day

GE Healthcare Portrait Core Services Software

A software vulnerability in the patient monitoring system may allow unauthorized access, causing loss of monitoring and missed alarms.

Moderate risk, FDA, Software defect

FilmArray NGDS Warrior Panel

The FilmArray NGDS Warrior Panel has mismatches between the outbreak strain and the reference strain used in its development.

Moderate risk, FDA, Device defect

GE Healthcare MAC VU360 Electrocardiographs

After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity.

Moderate risk, FDA, Software defect