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Medical device recalls

Medical device recalls from FDA, newest first.
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5 recalls

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

Halyard Purezero Ultraviolet Nitrile Exam Gloves

Nitrile exam gloves failed to meet chemical permeation performance specifications.

Moderate risk, FDA, Quality testing problem

Automated Impella Controller (AIC)

The Automated Impella Controller may interrupt motor control, have startup issues, or boot up improperly.

High risk, FDA, Device defect

3 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

Silastic Foley Catheters

Silastic Foley Catheters have a stain on their surface.

Moderate risk, FDA, Device defect

2 recalls

OneLIF Interbody Cage

The OneLIF Interbody Cage's inserter may fail to attach, causing procedural delays.

Moderate risk, FDA, Device defect

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

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

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

4 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

QuickVue Dipstick Strep A Test

The QuickVue Dipstick Strep A Test has the potential for false positive results.

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

3 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

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

2 recalls

BioCera Fibers and ZENBONE

BioCera Fibers bone void filler falls outside standard specifications.

Moderate risk, FDA, Device defect

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

8 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

Centinel Spine Prodisc C SK Total Cervical Disc Replacements

The Prodisc C SK U.S. Implant Extra Large 5mm and 6mm have a labeling mix-up.

Moderate risk, FDA, Labeling error

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

VOCSN V+Pro Package

The VOCSN V+Pro respiratory system may leak oxygen, reducing oxygen delivery and increasing fire risk.

High 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

North American Rescue AIDBAG First Aid Kits

AIDBAGs first aid kits contain a blood glucose system that can display an error code, leading to operator confusion and delayed treatment.

High risk, FDA, Software defect

Immuno-Mycologics Myco DDR Trident Neutralization Buffer B

Neutralization Buffer may contain contaminants.

Moderate risk, FDA, Contamination

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