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Medical device recalls

Medical device recalls from FDA, newest first.
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5 recalls

Cardioroot Woven Collagen Coated Vascular Graft

The Cardioroot Woven Collagen Coated Vascular Graft failed water permeability acceptance criteria.

Moderate risk, FDA, Device defect

Imager II Angiographic Catheters

Imager II Angiographic Catheters may fracture or detach, leading to device fragments remaining or migrating.

High risk, FDA, Device defect

1 recall

NGenuity Patient Monitor with Capnography (ETCO2)

The patient monitor can show a Checkline Error alarm at setup, which may delay the procedure.

Moderate risk, FDA, Device defect

2 recalls

ForeSight Elite Tissue Oximetry Cable

The ForeSight Elite Tissue Oximetry Cable has incorrect switching of channels 1 and 2 on the module and flag labels.

Moderate risk, FDA, Labeling error

Abiomed Impella Controllers

The Automated Impella Controller has defects in firmware and software that can affect pressure signal accuracy and cause unreliable signals.

Moderate risk, FDA, Software defect

8 recalls

Philips Achieva, Ingenia, Intera and MR MRI Systems

A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted.

Moderate risk, FDA, Software defect

Philips EPIQ Elite Diagnostic Ultrasound System

The Philips EPIQ Elite ultrasound system has a software issue that can cause inaccurate blood flow measurements and misdiagnosis.

Moderate risk, FDA, Software defect

Fresenius Medical Care CombiSet Hemodialysis Blood Tubing Sets

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Moderate risk, FDA, Device defect

Maquet PowerLED 300 Concealed Lighting System

The PowerLED 300 Concealed Lighting System can detach at the junction between the spring arm and suspension arm and fall, causing potential injury.

Moderate risk, FDA, Device defect

SeaSpine Mariner Deformity Extended Polyaxial Head

The spinal device has a thread depth out of design specification.

Moderate risk, FDA, Device defect

CooperSurgical INCA Infant Nasal CPAP Sets

The INCA Infant Nasal CPAP Complete Set may have a loose tubing connection, causing loss of pressure and reduced oxygenation.

High risk, FDA, Device defect

Midmark IQvitals Zone

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Moderate risk, FDA, Device defect

Olympus BiCOAG Hemostasis Probe

The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.

Moderate risk, FDA, Device defect

8 recalls

Captus 4000e Thyroid Uptake System

Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The Automated Impella Controller may have purge cassette recognition issues due to a purge flag component failure.

High risk, FDA, Device defect

Medline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery

Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.

Moderate risk, FDA, Sterility problem

Datex-Ohmeda Aisys Anesthesia Systems

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.

Moderate risk, FDA, Device defect

Boston Scientific StoneSmart Connect Console

The StoneSmart Connect Console has power adapters with higher-than-expected resistance in the electrical grounding path.

Moderate risk, FDA, Device defect

Howmedica Osteonics Orthopaedic Implant Components

Orthopaedic implant components made from aged Uhmwpe may oxidize, causing wear and potential harm.

Moderate risk, FDA, Device defect

Hemospray Endoscopic Hemostat

The hemostatic device has an issue with endoscope adherence and inability to spray powder.

Moderate risk, FDA, Device defect

Embecta Nano Pro Un-Cannulated Demo Samples

Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Moderate risk, FDA, Labeling error

3 recalls

GE Healthcare Centricity Enterprise Archive, Enterprise Archive, Centricity PACS, Centricity PACS Server, Workflow Core Services, and Core Services Hub Software

Centricity Enterprise Archive software may associate historical imaging data with the wrong patient, potentially causing misdiagnosis or delayed care.

Moderate risk, FDA, Device defect

Happiest Baby SNOO Sleep Sacks

Extra small and extra large SNOO Sleep Sacks have not been reviewed for safety and effectiveness by the FDA.

Moderate risk, FDA, Device defect

BD Alaris Pump Infusion Sets

BD Alaris Pump Infusion Sets have performance data discrepancies that may lead to inappropriate pump performance.

High risk, FDA, Device defect

1 recall

Medline Convenience Kits

Medline Convenience Kits contain sterile applicators that may have fungal contamination, potentially causing serious infections.

High risk, FDA, Contamination

8 recalls

Bayer Medical Care MEDRAD Stellant FLEX Syringe Kit

The syringe kit may not be properly sterilized due to a manufacturing issue.

Moderate risk, FDA, Device defect

Maquet Percutaneous Insertion Kits and Guidewires

The packaging may not consistently maintain sterile barrier integrity.

Moderate risk, FDA, Sterility problem

Carescape Central Station

Carescape Central Station may not resume patient monitoring for at least 3 minutes after restart, delaying recognition of events.

Moderate risk, FDA, Device defect

Bravo CF Capsule Delivery Device

Capsule may fail to attach to the esophagus or detach from the delivery device.

High risk, FDA, Device defect

Philips Patient Information Center iX and Philips PIC iX Essentials

Philips Patient Information Center iX may freeze and become unresponsive due to software malfunction.

Moderate risk, FDA, Software defect

StatStrip Glucose Meters

A software issue can cause the device to retain a previously scanned barcode, so a new patient's glucose result may be assigned to the previous patient's record.

High risk, FDA, Software defect

Bard Access Systems DuoGlide and Power-Trialysis Short-Term Straight Dialysis Catheter

Bard Access Systems is recalling its Power-Trialysis Short-Term Straight Dialysis Catheter because this is a downstream recall of class I recall RES 98777.

High risk, FDA, Device defect

ICU Medical IV and Oncology Administration Sets

Intravascular administration tubing sets may have black specks in drip chambers.

Moderate risk, FDA, Foreign object

4 recalls

Getinge PVC Thoracic Catheter

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Moderate risk, FDA, Quality testing problem

Lutronic DermaV Laser System

Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Moderate risk, FDA, Device defect

HeartSine Samaritan PAD Defibrillators SAM 350P, SAM 360P and SAM 450P

HeartSine SAM 350P, SAM 360P, and SAM 450P defibrillators have a damaged membrane tail causing an intermittent fault.

Moderate risk, FDA, Device defect

Bard Foley Catheter Trays and Intermittent Catheter Trays

Products that contain the Pericare Wipes may be contaminated on the surface.

Moderate risk, FDA, Contamination

2 recalls

Cardinal Health 200 Presource Packs Containing CliniClean Pericare Wipes Within BD Urinary Catheter Trays

The wipes in these catheter trays may be contaminated with a lubricant, causing skin irritation.

Moderate risk, FDA, Contamination

Fresenius Medical Care Acid Concentrates

GRANUFLO Dry Acid Concentrate, NaturaLyte, and Citrasate have complaints of blue-green discoloration.

Moderate risk, FDA, Device defect

1 recall

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

3 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

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

3 recalls

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

2 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