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Medical device recalls

Medical device recalls from FDA, newest first.
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6 recalls

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

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Medline Namic Guidewires, syringes, and kits have had regulatory clearances rescinded.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

2 recalls

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

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

1 recall

Stryker Sustainability Solution Color Cuff

The tourniquet cuffs can detach from the bladder at the welding connection.

Moderate risk, FDA, Device defect

1 recall

Brahms B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test

The B.R.A.H.M.S PlGF Plus Kryptor test may show out-of-range quality control values, potentially leading to falsely elevated sFlt-1/PlGF ratio results.

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

5 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

Oxoid Microbact Identification Kits Listeria 12L Kit

Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.

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

2 recalls

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

Waldemar Link Embrace Drill Towers

The Embrace Drill Tower has mixed-up article numbers in the surgical technique overview.

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

3 recalls

Philips Respironics Trilogy Evo Ventilators

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

High risk, FDA, Device defect

Merit Medical Hemodialysis Catheters and Sheath Introducer

Hemodialysis catheters and a sheath introducer may not split as intended.

High risk, FDA, Device defect

BD Alaris System with Guardrails Suite MX with Point of Care Unit

The BD Alaris System with Guardrails Suite MX with Point of Care Unit lacks labeling for secure Wi-Fi communication.

Moderate risk, FDA, Labeling error

1 recall

Olympus Cutting Forceps

The cutting forceps have defective welds that can cause the jaw to break during use.

Moderate risk, FDA, Device defect

3 recalls

Medtronic MiniMed 780G Insulin Pumps

The MiniMed 780G insulin pump with software versions 6.60 and 6.61 has software defects that could cause hypoglycemia or hyperglycemia.

Moderate risk, FDA, Software defect

BiDop 3 Pocket Doppler Blood-Flow Detectors

The BiDop 3 Pocket Doppler has a fetal indication for use that is not cleared.

Moderate risk, FDA, Unapproved product

Philips Ultrasound Transducers

Philips ultrasound transducers lack labelling to define their useful life.

Low risk, FDA, Labeling error

4 recalls

I.T.S. Orthopedic Plates and Screws

Volar Radius Plate with Angular Stability may cause higher temperature increases under certain MRI conditions.

Moderate risk, FDA, Device defect

Erbe Flexible Cryoprobes

Flexible Cryoprobes may rupture or burst during activation.

High risk, FDA, Device defect

Olympus Endoscope Valves and Reprocessors

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Moderate risk, FDA, Device defect

GE Medical Systems Imactis CT-Navigation Systems

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Moderate risk, FDA, Device defect