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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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3 recalls that day

Jolife LUCAS Chest Compression System

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

Moderate risk, FDA, Device defect

4 recalls that day

GE HealthCare Revolution CT Scanners

GE HealthCare has identified a potential security vulnerability in certain Revolution CT systems.

Moderate risk, FDA, Software defect

Namic Manifolds and Kits

Medline has identified the presence of particulate within the fluid path of the Manifolds.

High risk, FDA, Foreign object

Donjoy IceMan CLASSIC3 Cold Therapy Unit

Donjoy IceMan CLASSIC3 cold therapy unit have a broken connector that may interrupt prescribed cold therapy.

Moderate risk, FDA, Device defect

On-X Mitral Heart Valve with Conform-X Sewing Ring

The On-X Mitral Heart Valve with Conform-X Sewing Ring was released before all required testing was complete.

Moderate risk, FDA, Device defect

2 recalls that day

BioCera Fibers and ZENBONE

Orthorebirth is recalling its Zenbone and BioCera Fibers because of Resorbable bone void filler falls outside standard specifications.

Moderate risk, FDA, Device defect

Medline Convenience Kits, Surgical Drapes, Gowns and Packs

Medline identified issues related to calibration of the equipment used to sterilize and package the devices.

Moderate risk, FDA, Sterility problem

7 recalls that day

BioFire Joint Infection (JI) Panel

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

Moderate risk, FDA, Contamination

Mint Lesion

Mint Lesion can lose or incorrectly link information when its connection is interrupted during a read.

Moderate risk, FDA, Device defect

DFI One Step and QUCARE In Vitro Diagnostic Tests

The devices were distributed without required FDA premarket clearance or approval.

Moderate risk, FDA, Unapproved product

Medline Namic Angiographic Control Syringes Convenience Kits

Convenience kits containing syringes with a rotating adaptor may unwind during use, causing loose or full disconnection.

High risk, FDA, Device defect

Biofire Spotfire Respiratory/Sore Throat Panel

The Biofire Spotfire Respiratory/Sore Throat Panel may result in false negative results and control failures.

Moderate risk, FDA, Device defect

Medical Action Industries Pack Cath BHH

Pack Cath BHH contains a syringe whose rotating adapter may unwind, causing loose or full disconnection.

High 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 that day

Physio-Control LIFEPAK 15

Some defibrillators were serviced without a Performance Inspection Procedure.

Moderate risk, FDA, Device defect

9 recalls that day

Spacelabs Ultraview SL Command Module

The Spacelabs Ultraview SL Command Module has a manufacturing issue due to a malfunctioning electrical leakage tester.

Moderate risk, FDA, Manufacturing problem

Centinel Spine Prodisc C SK Total Cervical Disc Replacements

Prodisc C SK U.S. implants have a labeling mix-up, with 5mm and 6mm sizes mislabeled.

Moderate risk, FDA, Labeling error

Halyard Cardiac Cath and Cath Lab Kits

The syringe rotating adaptor may unwind during use.

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

LUX-DX II and LUX-Dx II Plus Arrythmia detectors and alarms 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

Erbeflo CleverCap CO2 and other tubing/cap sets for endoscopes 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 sub-assembly that may be susceptible to breaking.

Moderate risk, FDA, Device defect

VOCSN V+Pro Package

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

High risk, FDA, Device defect

Intuitive 8 mm SureForm 30 Gray Reloads

Intuitive 8 mm SureForm 30 Gray Reloads may produce an incomplete staple line.

High risk, FDA, Device defect

2 recalls that day

Medline and Centurion Medical Convenience Kits

Medical convenience kits containing Webcol Large Alcohol Prep Pads may be non-sterile due to a contaminant.

Moderate risk, FDA, Sterility problem

Medline Neuro Sponges

Medline Neuro Sponges may have higher-than-expected endotoxin levels.

Moderate risk, FDA, Quality testing problem

11 recalls that day

North American Rescue AIDBAG First Aid Kits

AIDBAGs first aid kits contain a blood glucose system that can show an error code, delaying treatment.

High risk, FDA, Software defect

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.

Moderate risk, FDA, Sterility problem

Siemens Epoc BGEM BUN Test Cards

Use of the affected product can result in discrepant low pH and measured total carbon dioxide results.

Moderate risk, FDA, Device defect

Straumann N!Ce Full-Arch Restorations

Includes an incorrect screw seat interface.

Moderate risk, FDA, Device defect

Becton Dickinson BD GasPak EZ CO2 and Campy Pouch Systems

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems.

Moderate risk, FDA, Device defect

Merit Medical Systems Philips Bridge Prep Kit

The Philips Bridge Prep Kit may have a catheter that resists advancement over a guidewire.

Moderate risk, FDA, Device defect

Abbott Point of Care 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 may have locking mechanisms that do not secure properly, shifting coordinates during procedures.

Moderate risk, FDA, Device defect

Heraeus PALAMIX Duo and Uno

In units older than 1.5 years, the mixing rod may come loose from its lock during the mixing process.

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 that day

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 that day

Philips MRI Systems with MR Elastography

Philips Achieva 1.5T with MR Elastography (MRE) may show 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 fails to require a tool for replacement.

Moderate risk, FDA, Device defect

8 recalls that day

Medtronic Sphere-9 Catheter

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

Moderate risk, FDA, Device defect

Zimmer Disposable Mixing Bowls with Spatula

Disposable Mixing Bowls with Spatula have package seal issues that may 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

Updated software is available for the Accolade family of pacemakers and CRT-Ps, and the advisory population is expanding to include all CRT-P and DR-EL devices.

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 may be operated outside its validated configuration due to user modification of settings.

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 that day

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

Hamilton HxRunControl software may have spontaneous closures during Autolys protocols after deployment of the PCT software.

Moderate risk, FDA, Software defect

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

The balloon dilator's inflation tag may have incorrect part numbers and sizes.

Moderate risk, FDA, Labeling error