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Medical device recalls

Medical device recalls from FDA, newest first.
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2 recalls

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System

The Insertable Cardiac Monitor System may delay AF Burden Alert notifications, potentially delaying clinical evaluation.

Moderate risk, FDA, Software defect

4 recalls

Medline Convenience Kits with BD ChloraPrep Applicators

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators may have an open or incomplete seal, leading to infection.

Moderate risk, FDA, Contamination

Baxter Novum IQ Syringe Pump

The syringe pump has a software issue that may occur during multi-syringe infusion.

Moderate risk, FDA, Software defect

Johnson & Johnson HEALON EndoCoat PRO and HEALON DUET PRO II

Viscoelastic products used in cataract procedures may cause corneal abrasion, iris trauma, or descemet's membrane detachment if forced.

Moderate risk, FDA, Device defect

Medline Convenience Kits

Medline Convenience Kits contain applicators with a potential breach of sterility in the packaging.

Moderate risk, FDA, Sterility problem

1 recall

STA Staclot Protein S

STA Staclot Protein S has a positive drift in QC values within its stated 4-hour onboard stability period.

Moderate risk, FDA, Device defect

4 recalls

ICU Medical IV Sets with Drip Chambers

IV Sets with drip chambers may have black specks which could result in a delay in therapy.

Moderate risk, FDA, Device defect

IMRIS Operating Room Tables ORT200 and ORT300

The ORT200 operating room table may have a mechanical failure that prevents locking, posing a risk of injury.

Moderate risk, FDA, Device defect

Healthmark ProChek Protein Tests

The ProChek tests were made with an expired ingredient, which may cause false results.

Moderate risk, FDA, Device defect

Fresenius Medical Care 2008T BlueStar Hemodialysis Machine

The 2008T BlueStar Hemodialysis Machine has received complaints about flow-, no water-, or temperature-related alarms.

Moderate risk, FDA, Device defect

2 recalls

Henry Schein Structur 2 SC and Grandio Restorative Materials

Structur 2 SC Temporary Resin Cartridge Refill was distributed with incorrect packaging and instructions.

Moderate risk, FDA, Device defect

Midmark Digital ECG HD+12 and IQecg Digital ECG

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Moderate risk, FDA, Device defect

3 recalls

Philips Incisive CT with Software V4.5&V5.0

Philips Incisive CT may fail to trigger a clinical scan during Bolus Tracking.

Moderate risk, FDA, Device defect

Hollister Onli Hydrophilic Urethral Intermittent Catheters

The Onli 17cm Hydrophilic Urethral Intermittent Catheter may have a protrusion that could cause genitourinary trauma or bleeding.

Moderate risk, FDA, Manufacturing problem

Medline Medical Convenience Kits

Medline medical convenience kits contain neurosponges with potential out-of-specification endotoxin levels.

Moderate risk, FDA, Quality testing problem

1 recall

Boston Scientific ENROUTE Transcarotid Neuroprotection System

The ENROUTE Transcarotid Neuroprotection System has a potential for arterial sheath tip separation during use.

High risk, FDA, Device defect

1 recall

Esteem Body Soft Convex Urostomy Pouch

Esteem Body Soft Convex Urostomy Pouch may leak from cap during use.

Moderate risk, FDA, Device defect

1 recall

Beckman Coulter DxC 500I Clinical Analyzer Modules

Beckman Coulter DxC 500i Clinical Analyzer Modules have a software defect that can cause erroneous patient test results.

Moderate risk, FDA, Software defect

10 recalls

Paragon 28 Navicular Cage Foot Implants

The foot implant has elevated oxygen levels that may reduce material ductility.

Low risk, FDA, Device defect

Blanketrol II, Blanketrol III, and Innercool Coolblue Console

The Blanketrol II thermal regulating system may shut down due to overheating of its 115V CPU board.

Moderate risk, FDA, Device defect

Paragonix Technologies KidneyVault Portable Renal Perfusion System

The KidneyVault Portable Renal Perfusion System may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Moderate risk, FDA, Software defect

Boston Scientific OverStitch Suture Cinch and Suture Cinch Long

The OverStitch Suture Cinch may fail to deploy the cinch implant or cut the suture.

Moderate risk, FDA, Device defect

Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device

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

Moderate risk, FDA, Device defect

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

The Cardiac Workstation 5000 may 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

One-Piece Guedel Airway devices could potentially be occluded or partially occluded.

Moderate risk, FDA, Device 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

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 received adequate sterilization processing.

Moderate risk, FDA, Sterility problem

1 recall

Erbe USA ERBECRYO 2 Cryosurgical Unit

The ERBECRYO 2 Cryosurgical Unit can rupture its cryoprobe due to excessive pressure from a strong pull on the hose.

Moderate risk, FDA, Device defect

3 recalls

Straumann Bone Level Tapered (BLT) Implant

The Straumann Bone Level Tapered Implant may contain implants that are 12mm instead of 14mm.

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

The 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

3 recalls

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

The ER-Spec vaginal speculum may have a burr on the blade, introducing a sharp edge for patients and providers.

Moderate risk, FDA, Device defect

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

5 recalls

Thermo Fisher Diagnostics Neisseria Meningitidis Gp C Tests

Neisseria meningitidis Gp C 2ml/VL is not performing to IFU criteria, not positive to ATCC13102 within 60 seconds.

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 before the end of their shelf life.

Moderate risk, FDA, Contamination

Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices

V-Loc 90 Absorbable Wound Closure Device may have a perforation or tear in its sterile barrier packaging, which may lead to infection or prolonged surgery.

Moderate risk, FDA, Sterility problem

Xhibit Central Station

The Xhibit Central Station has audio/video failures due to a display port component.

Moderate risk, FDA, Device defect

Roche Navify Digital Pathology Software

Navify Digital Pathology software has an image/metadata discrepancy with the Viewer window.

Moderate risk, FDA, Device defect

3 recalls

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

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 active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 and GEM Premier 5000 PAK lots did not meet established manufacturing specifications.

Moderate risk, FDA, Device defect

5 recalls

Medline Hudson RCI Heated Neonatal Breathing Circuits

Neonatal and infant heated wire breathing circuits may experience sporadic failure.

Moderate risk, FDA, Device defect

Siemens Healthcare Diagnostics Atellica CH Urine Albumin

Atellica CH Urine Albumin tests may cause falsely depressed urea nitrogen and hemoglobin A1c results.

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

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)

Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.

Moderate risk, FDA, Device defect