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Medical device recalls

Medical device recalls from FDA, newest first.
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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

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

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

4 recalls

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

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

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

1 recall

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

2 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

B. Braun Hemodialysis Bloodlines

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

High 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

4 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

Philips AneurysmFlow

Philips AneurysmFlow software may not provide reliable prognostic information about aneurysm occlusion after Flow Diverter Stent treatment.

Moderate risk, FDA, Device defect

Arjo Tenor Mobile Passive Patient Lift

The Arjo Tenor mobile passive patient lift has an internal actuator component that may not meet required mechanical strength.

Moderate risk, FDA, Device defect

Beta Bionics iLet Ace Pump Kit and Dosing Decision Software

The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and potentially causing severe hypoglycemia.

Moderate risk, FDA, Device defect

3 recalls

Medline Namic Angiographic Control Syringes and Medical Convenience Kits

NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may unwind during use, causing a loose or full disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno and Artis Icono Biplane Systems

ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.

Moderate risk, FDA, Device defect

Spacelabs Healthcare Multi-Parameter Command Module

The Multi-parameter Command Module has a circuit board issue that may cause inaccurate readings and delayed care.

Moderate risk, FDA, Device defect

1 recall

Tornier HRS Max Tuberosity Bodies and Trial

Tornier HRS Max parts were incorrectly labeled and are incompatible with the HRS Max system.

Moderate risk, FDA, Labeling error

4 recalls

Medtronic MiniMed and Paradigm Insulin Pumps

Over-delivery can cause severe hypoglycemia, altered mental status, seizure, coma, or death.

Moderate risk, FDA, Device defect

Burlington Medical Radiation Protection Apparel

Burlington Medical BAT Coverage may degrade over time, decreasing its lifespan.

Moderate risk, FDA, Device defect

Philips Respironics Trilogy EV300, Evo, Evo O2, and Evo Universal

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

High risk, FDA, Device defect

Cardinal Health Monoject Tuberculin Syringes

The outer packaging and blister pack label the product as a 1mL Luer Lock Tuberculin Syringe, but the syringes inside are U-100 Insulin syringes.

Moderate risk, FDA, Labeling error

3 recalls

Synthes 2.4 Volt Tap Locking and Cortex Screws

Bone taps have an incorrect thread due to a lot swap.

Moderate risk, FDA, Device defect

Olympus SOLTIVE Premium and Pro Laser Systems

The Soltive Pro and Premium laser systems may become inoperable and emit smoke or a burning smell.

Moderate risk, FDA, Device defect

Intuitive Surgical da Vinci S and Si Endoscopic Instruments

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Moderate risk, FDA, Device defect

8 recalls

Mentor Breast Tissue Expanders

Artoura Breast Tissue Expanders may have infusion sets with dull or blunt needle tips that may be difficult to advance and/or break.

Moderate risk, FDA, Device defect

Philips Allura Xper and Azurion Angiography Systems

Philips Allura Xper and Azurion systems may not initiate X-ray imaging or may do so intermittently when using the wired foot switch.

Moderate risk, FDA, Device defect

Medline Enfit g-Tube Connector

The ENFIT G-TUBE CONNECTOR may not seal properly, leading to leakage that could cause delayed care and fluid loss.

Moderate risk, FDA, Device defect

Ultradent Jiffy Original Composite Polisher Cups

Jiffy Original Composite Polisher Cups may crumble and break apart easily, which could cause a delay in patient treatment.

Moderate risk, FDA, Device defect

Stryker CHROMOPHARE Softlit Ring Surgical Light System

The surgical light system may not adequately support the weight of the ceiling cover.

Moderate risk, FDA, Device defect

Philips Vue Motion V12

Vue Motion V12 may display image frames out of sequence during dynamic cine runs.

Moderate risk, FDA, Device defect

Puracol and Puracol Plus Collagen Wound Dressings

Puracol and Puracol Plus Collagen Wound Dressings have elevated endotoxin levels that may cause strong inflammatory response.

Moderate risk, FDA, Contamination

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

Atellica CH Enzymatic Hemoglobin A1c (A1c_E) may show depressed results when used with RCRP on the same analyzer, potentially delaying diabetes diagnosis.

Moderate risk, FDA, Device defect