Skip to main content
RecallsAboutBlog

Medical device recalls

Medical device recalls from FDA, newest first.
FiltersSort Newest
Agency
Risk level
Date
Sold in

11 recalls

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

Merit Medical Systems Philips Bridge Prep Kit

Philips Bridge Prep Kit may experience resistance when advanced over a guidewire.

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

Beta Bionics iLet Bionic Pancreas

The iLet Bionic Pancreas software may delay CGM readings, leading to severe hyperglycemia or hypoglycemia.

Moderate risk, FDA, Software 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

8 recalls

Medtronic Sphere-9 Catheter

The Sphere-9 Catheter can cause ventricular fibrillation during RF therapy in patients with certain Biotronik defibrillators.

Moderate risk, FDA, Device defect

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

Boston Scientific Essentio, Proponent, Valitude and Visionist Pacemakers

Boston Scientific pacemakers may have a software issue that could affect therapy.

High risk, FDA, Software defect

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

WHILL Model C2 and Model F Powered Wheelchairs

Cyber vulnerability of BLE communication was found by Cisa VDP program.

High 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

9 recalls

Windstone Medical Packaging Custom Convenience Kits Pre Op Kits

Custom Convenience Kits Pre Op Kit - NS may allow backflow of medication from secondary IV containers into primary containers.

Moderate risk, FDA, Device defect

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

Foundation Medicine FoundationOne CDx Sequencing Agent

Sequencing Agent SEQ0067 may increase phasing, potentially causing false-positive BARD1 splice site indel artifact variants.

Moderate risk, FDA, Device defect

LSL Healthcare Central Line Dressing, Foley Urine Collection, IV Start and Wound Closure Kits

Medical procedure kits contain alcohol prep pads that may not be sterile.

Moderate risk, FDA, Sterility problem

Arrow International Catheters and Introducer Kits

Arrow International Catheters and Introducer Kits have liquid adhesive that was incorrectly manufactured.

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

SurgiSmoke Solutions Flamingo Funnel

Flamingo Funnels were made with a non-gamma sterilization compatible drape.

Moderate risk, FDA, Manufacturing problem

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

8 recalls

Uvlizer Ultraviolet-C Germicidal Wands

The handheld ultraviolet-C germicidal wand can expose nearby persons to UVC radiation above safety limits.

Moderate risk, FDA, Device defect

Uvlizer Handheld Ultraviolet-C Germicidal Wands

A handheld ultraviolet-C germicidal wand can expose nearby persons to UVC radiation above safety limits.

Moderate risk, FDA, Device defect

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

Olympus Thunderbeat II Shears w/Ultrasonic Mode

Olympus Thunderbeat II Shears w/Ultrasonic Mode may have a distal tip component that detaches during use.

Moderate risk, FDA, Device defect

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

Integra LifeSciences CUSA Clarity C7000 Console

The CUSA Clarity C7000 Console has a software issue that renders the touch screen unresponsive.

Moderate risk, FDA, Software 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

6 recalls

Windstone Medical Packaging Custom Convenience Kits with Medline Namic Angiographic Control Syringes

Custom Convenience Kits contain syringes whose rotating adapter can unwind during use, risking loose connection or disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno Angiography Systems

ARTIS Pheno VE30A and VE40A may capture lighter and darker patient images, causing less accurate 3D reconstruction.

Moderate risk, FDA, Device defect

Medline CENTURION Circumcision Kit

The CENTURION Circumcision Kit was distributed without required sterilization and is not sterile.

Moderate risk, FDA, Sterility problem

Gentuity HF-OCT Imaging System

The Gentuity HF-OCT Imaging System may show repeated frames during pullback, affecting length measurements.

Moderate risk, FDA, Software defect

Philips Spectral CT on Rails

Philips Spectral CT on Rails has software issues that could cause the gantry to remain at the current scan position.

Moderate risk, FDA, Software defect

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

4 recalls

Cytal Wound and Burn Matrices

Cytal Wound Matrix and Cytal Burn Matrix have an increased rate of out-of-specification endotoxin results.

Moderate risk, FDA, Quality testing problem

React Health PHOENIX 5L Oxygen Concentrator

The React Health PHOENIX 5L Oxygen Concentrator was distributed without meeting internal quality specifications.

Moderate risk, FDA, Quality testing problem

B. Braun Hemodialysis Bloodlines

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

High risk, FDA, Device defect

Clariance Elegance Anterior Cervical Plates

Elegance cervical plates have a burr on the finished product.

Moderate 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

5 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