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Medical device recalls

Medical device recalls from FDA, newest first.
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3 recalls

Philips Azurion, Allura and Integris-Allura Systems

The Azurion system's deaeration hose may degrade, potentially causing oil leakage that affects cooling performance.

Moderate risk, FDA, Device defect

Silastic Foley Catheters

Silastic Foley Catheters have a stain on their surface.

Moderate risk, FDA, Device defect

1 recall

Medtronic Gundry and DLP Retrograde Cannulas

Medtronic retrograde cannulas may have a sterile barrier breach.

Moderate risk, FDA, Sterility problem

1 recall

ICU Medical ChemoLock Oncology Kits and Transfer Sets

Oncology sets may leak, causing therapy interruption and possible exposure to hazardous substances.

Moderate risk, FDA, Device defect

2 recalls

Tangent Endoscopy Single Use Digital Catheter

The Tangent Single Use Digital Catheter can fracture at the distal shaft tip.

Moderate risk, FDA, Device defect

Swan-Ganz Catheter

Swan-Ganz Catheters may leak or break at the blue proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Moderate risk, FDA, Device defect

4 recalls

Codman CerebroFlo EVD Catheter with Endexo Technology

The CerebroFlo EVD Catheter has an out-of-specification endotoxin result that did not meet acceptance criteria.

Moderate risk, FDA, Quality testing problem

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

Edwards EVOQUE Tricuspid Delivery System

The Edwards EVOQUE tricuspid delivery system has a labeling update to warn if its function is compromised.

Moderate risk, FDA, Labeling error

3 recalls

ZYMUTEST HIA IgG, in Vitro Diagnostic ELISA Kit

The ZYMUTEST HIA IgG kit may have incorrect values for the positive control.

Moderate risk, FDA, Device defect

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

3 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

Donjoy IceMan CLASSIC3 Cold Therapy Unit

The IceMan CLASSIC3 cold therapy unit has a broken connector that may interrupt prescribed cold therapy.

Moderate risk, FDA, Device defect

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

3 recalls

BioFire Joint Infection (JI) Panel

The BioFire Joint Infection Panel may be contaminated, leading to false positives.

Moderate risk, FDA, Contamination

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

1 recall

Physio-Control LIFEPAK 15

Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.

Moderate risk, FDA, Device defect

7 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

AVID Medical Halyard Cardiac Cath and Cath Lab Kits

Halyard cardiac cath packs and kits may have a syringe adaptor that can unwind, causing loose or full disconnection.

High risk, FDA, Device defect

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

7 recalls

Immuno-Mycologics Myco DDR Trident Neutralization Buffer B

Neutralization Buffer may contain contaminants.

Moderate risk, FDA, Contamination

Depuy Synthes Attune Revision Hinge Femoral

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Moderate risk, FDA, Sterility problem

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

5 recalls

Zimmer Disposable Mixing Bowls with Spatula

Disposable Mixing Bowls with Spatula may have incomplete or peeling seals, which could lead to infection.

Moderate risk, FDA, Sterility problem

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

2 recalls

Protocol Configuration Tool (PCT) Software v1.3.0 for Hamilton AutoLys STAR

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Moderate risk, FDA, Software defect

Diversatek Healthcare Viper 3-Stage Fixed Wire and Wire Guided Balloon Dilator

The balloon dilator's inflation tag may list incorrect balloon sizes and pressures.

Moderate risk, FDA, Labeling error

5 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

Oxoid Agglutinating Sera, Salmonella 9-0

Oxoid Agglutinating Sera, Salmonella 9-0 is not performing to IFU criteria, showing cross reactions.

Moderate risk, FDA, Quality testing problem