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Medical device recalls

Medical device recalls from FDA, newest first.
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2 recalls

Arrow Hemodialysis Catheters

Arrow Hemodialysis Catheters may not split as intended, causing withdrawal resistance, pain, bleeding, and tissue injury.

High risk, FDA, Device defect

Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters

Reprocessed electrophysiology catheters have incomplete seals on sterile product.

Moderate risk, FDA, Sterility problem

2 recalls

Philips Azurion

Philips Azurion has bolts and plastic parts that may loosen or break.

Moderate risk, FDA, Device defect

Hologic Selenia Dimensions and 3Dimensions Mammography Systems

Selenia Dimensions Mammography Systems can develop loose, missing, or broken internal bolts over time.

Moderate risk, FDA, Device defect

2 recalls

Dexcom G7 CGM iOS, G7 CGM watchOS, and ONE+ iOS CGM App

The Dexcom G7 CGM iOS App has a software defect that can delay glucose alerts.

Moderate risk, FDA, Software defect

Jolife LUCAS Chest Compression System

LUCAS chest compression systems may have service records that do not justify passing results.

Moderate risk, FDA, Device defect

2 recalls

GE HealthCare Revolution CT Scanners

GE HealthCare computed tomography systems have a potential security vulnerability that could impact AW Server via Edison Health Link.

Moderate risk, FDA, Software defect

Namic Manifolds and Kits

Namic Angiographic Manifolds contain particulate within the fluid path.

High risk, FDA, Foreign object

1 recall

Medline Convenience Kits, Surgical Drapes, Gowns and Packs

Medline Convenience Kits and Surgical Drapes may not be sterile due to calibration issues with sterilization equipment.

Moderate risk, FDA, Sterility problem

2 recalls

Mint Lesion

If the connection between a Mint Lesion workstation and the server is interrupted while performing a read, some information may be lost or incorrectly linked to other patients.

Moderate risk, FDA, Device defect

DEX Ophthalmic Tissue Forceps

DEX Ophthalmic Tissue Forceps have a field safety corrective action for their instructions for use.

Moderate risk, FDA, Device defect

6 recalls

Spacelabs Ultraview SL Command Module

The Spacelabs Ultraview SL Command Module has a manufacturing issue with its electrical leakage tester.

Moderate risk, FDA, Manufacturing problem

Cook Centimeter Sizing Catheters

Marker bands may be at an increased risk of cracking/breakage.

High risk, FDA, Device defect

Boston Scientific LUX-Dx II Arrhythmia Detectors and Alarms

The LUX-DX II Arrythmia detector and alarm may not collect PVC Burden data or monitor for Bradyarrhythmia and Pause.

Moderate risk, FDA, Software defect

Erbe ERBEFLO CleverCap CO2 Tubing and Cap Sets

The Erbeflo CleverCap CO2 Hybrid CO2 Tubing/Cap Set may allow unintended water flow, leading to water aspiration and respiratory failure.

Moderate risk, FDA, Device defect

Da Vinci X, Xi Surgical System

The da Vinci X and Xi surgical systems have screws in the arm that may break.

Moderate risk, FDA, Device defect

Intuitive 8 mm SureForm 30 Gray Reloads

The reloads may potentially produce an incomplete staple line.

High risk, FDA, Device defect

1 recall

Medline and Centurion Medical Convenience Kits

Medical convenience kits containing Webcol Large Alcohol Prep Pads may not be sterile due to a contaminant.

Moderate risk, FDA, Sterility problem

5 recalls

Siemens Epoc BGEM BUN Test Cards

The affected product can result in discrepant low pH and measured Total Carbon Dioxide results.

Moderate risk, FDA, Device defect

Becton Dickinson BD GasPak EZ CO2 and Campy Pouch Systems

BD GasPak EZ CO2 Pouch System may produce carbon dioxide levels below specification.

Moderate risk, FDA, Device defect

Abbott i-STAT EG7+, EG6+, and G3+ Cartridges

I-STAT cartridges may report higher PCO2 and lower pH results, appearing as severe respiratory acidosis.

Moderate risk, FDA, Manufacturing problem

Leksell Vantage Arc System

The Leksell Vantage Arc System has locking mechanisms that may not secure properly, causing coordinate shifting.

Moderate risk, FDA, Device defect

Heraeus PALAMIX Duo and Uno

The PALAMIX uno mixing rod may come loose during mixing in units older than ̈1.5 years.

Low risk, FDA, Device defect

1 recall

Siemens Healthcare Diagnostics Dimension Creatinine Flex Reagent Cartridge

This imprecision may lead to erroneously decreased or increased creatinine patient results.

Moderate risk, FDA, Device defect

2 recalls

Philips MRI Systems with MR Elastography

Philips Achieva 1.5T with MR Elastography may display stiffness values that are too small.

Moderate risk, FDA, Software defect

HiResolution Bionic Ear System M Zn-Air Battery Pak

The M Zn-Air Battery Pak has a battery door that does not require a tool to replace the button/coin cell battery.

Moderate risk, FDA, Device defect

4 recalls

Milestone Vacuum Bag SU Large Specimen Containers

The non-sterile specimen container may have reagent leakage.

Moderate risk, FDA, Device defect

Healthmark Mesh Style Tip Protectors

Mesh Style Tip Protectors lack FDA clearance.

Moderate risk, FDA, Unapproved product

Kiwi Omni Vacuum Delivery System

Due to complaints of device breakage at the traction force gauge to handle joint.

Moderate risk, FDA, Device defect

Genius Review Station Display (Barco Monitor)

The Genius Review Station Display can be operated outside its validated configuration due to user modifications.

Moderate risk, FDA, Device defect

3 recalls

Micro-X Rover Mobile X-Ray System

The Rover Mobile X-ray System may malfunction, causing the X-ray to be inoperable.

Moderate risk, FDA, Device defect

Beckman Coulter Access Total T4 Calibrator

The Access Total T4 Calibrator shows a negative bias on DxI 600/800 instruments, with slopes outside specifications.

Moderate risk, FDA, Device defect

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes

The OER-ELITE Endoscope Reprocessor Connecting Tubes may have lock levers that fail prematurely.

Moderate risk, FDA, Device defect

2 recalls

nanOss 3D Advanced Bone Graft Substitute

The bone graft substitutes were incorrectly labeled with a 5-year shelf life instead of the approved four years.

Moderate risk, FDA, Labeling error

Davol Avitene Ultrafoam Microfibrillar Collagen Hemostat

Avitene Ultrafoam Microfibrillar Collagen Hemostat may contain foreign matter, confirmed to be inspect fragments.

Moderate risk, FDA, Foreign object

4 recalls

Medline Guidewires, Syringes and Kits

Medline Namic Guidewires, syringes, and kits have had regulatory clearances rescinded.

Moderate risk, FDA, Device defect

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Medline Convenience Kits with 10mL polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

Magellan Diagnostics LeadCare Blood Lead Test Kits

LeadCare blood lead test kits may show falsely elevated results when used with certain third-party micro-collection devices.

Moderate risk, FDA, Device defect

Angiodynamics AccuVu and Soft-Vu Angiographic Catheter

A manufacturing defect may prevent the guidewire from passing through the catheter hub.

Moderate risk, FDA, Manufacturing problem

1 recall

Cellex Photopheresis System CELLEX Photopheresis Kit

The Cellex Photopheresis Kit has increased difficulty installing the centrifuge bowl, which may dislodge and break, causing treatment delay and blood loss.

Moderate risk, FDA, Device defect

1 recall

B. Braun Hemodialysis Bloodlines

B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line.

High risk, FDA, Device defect

1 recall

Cook Instinct Plus Endoscopic Clipping Device

The Instinct Plus Endoscopic Clipping Device may malfunction due to increased complaints.

Moderate risk, FDA, Device defect

4 recalls

Remel Yeastone Broth

Yeastone Broth may report incorrect AST results during quality control, potentially causing delayed response or need to change antifungal agent.

Moderate risk, FDA, Device defect

Philips AneurysmFlow

Philips AneurysmFlow software may not provide reliable prognostic information about aneurysm occlusion after Flow Diverter Stent treatment.

Moderate risk, FDA, Device defect

Arjo Tenor Mobile Passive Patient Lift

The Arjo Tenor mobile passive patient lift has an internal actuator component that may not meet required mechanical strength.

Moderate risk, FDA, Device defect

Beta Bionics iLet Ace Pump Kit and Dosing Decision Software

The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and potentially causing severe hypoglycemia.

Moderate risk, FDA, Device defect

2 recalls

Medline Namic Angiographic Control Syringes and Medical Convenience Kits

NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may unwind during use, causing a loose or full disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno and Artis Icono Biplane Systems

ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.

Moderate risk, FDA, Device defect

1 recall

Molded Products Luer Cap Sets

The See Luer Cap Set has a threaded sleeve that may not be engaged and can become unattached.

Moderate risk, FDA, Device defect

1 recall

Tornier HRS Max Tuberosity Bodies and Trial

Tornier HRS Max parts were incorrectly labeled and are incompatible with the HRS Max system.

Moderate risk, FDA, Labeling error