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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

Daavlin Phothera 200 Phototherapy Devices

Phothera 200 Phototherapy Devices have calibration certificates with reversed outputs.

Moderate risk, FDA, Device defect

3 recalls

CASE v7.0 Cardiac Testing System

The CASE v7.0 Cardiac Testing System can spark at the printer head, potentially causing serious thermal injury.

Moderate risk, FDA, Device defect

Covidien EndoStitch Polysorb Single Use Loading Unit

The Covidien EndoStitch Polysorb Single Use Loading Unit may have holes in its pouch, compromising the sterile barrier.

Moderate risk, FDA, Sterility problem

Philips Azurion 3M12, 3M15, 5M12 and Other Angiography Systems

Philips Azurion systems may show a dark image during Roadmap Pro, not clinically usable.

Moderate risk, FDA, Device defect

1 recall

Becton Dickinson & Company BD Spinal Trays

BD Spinal Trays with Quincke or Whitacre needles have quality deficiencies related to acceptance testing.

High risk, FDA, Device defect

4 recalls

Medtronic 1x4 and 2x4 Pocket Adaptor Kit for Deep Brain Stimulation

The Medtronic Pocket Adaptor Kits are labeled with incorrect Use-By-Dates.

Moderate risk, FDA, Labeling error

Medline Anesthesia and Spinal Trays

Medline kits containing Huons Bupivacaine in Dextrose Injection have quality issues, including data integrity concerns and efficacy complaints.

High risk, FDA, Device defect

Philips Azurion and Allura Systems

The Azurion system may show decreased performance as it ages, potentially causing loss of imaging functionality.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The Automated Impella Controller has alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing.

High risk, FDA, Device defect

1 recall

HydroMARK Breast Biopsy Site Marker

The HydroMARK Breast Biopsy Site Marker has incorrect inner package labeling.

Moderate risk, FDA, Labeling error

1 recall

Omnipod 5 Pods, Omnipod DASH Pod, and Omnipod (Eros) Pod

Omnipod insulin pods may leak insulin due to cannula damage, causing under-delivery and high blood glucose.

High risk, FDA, Device defect

2 recalls

Philips Azurion Systems

Philips Azurion systems may have table movements impacted due to mechanical wear of the Float Tabletop control.

Moderate risk, FDA, Device defect

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

1 recall

Medtronic Gundry and DLP Retrograde Cannulas

Medtronic retrograde cannulas may have a sterile barrier breach.

Moderate risk, FDA, Sterility problem

1 recall

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

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

Technological Medical Advancements Diowave Laser System

The Diowave Laser System operates beyond its cleared power output.

Moderate risk, FDA, Software 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