Olympus High Flow Insufflation Unit - UHI-4
The Olympus High Flow Insufflation Unit can have its front panel display turn off unexpectedly, and air delivery ceases.
Medical device recalls
Medical device recalls from FDA, newest first.
4 recalls
3 recalls
Olympus 4K UHD LCD Monitor
The Olympus 4K UHD LCD Monitor can have faulty HDMI and DisplayPort connectors, causing image loss or abnormalities.
Boston Scientific FARADRIVE Steerable Sheath Clear
The FARADRIVE Steerable Sheath Clear can have valve damage that may cause air ingress and potential air embolism.
4 products
AVID Medical Halyard Eye Pack Convenience Kit
The Halyard Eye Pack Convenience kit contains an incorrect concentration of Betadine solution.
3 recalls
Ferno Power F2 Powered Fastening System
The Power F2 Powered Fastening System may experience accelerated roller wear and deformation, causing the rail to lodge and delaying patient transport.
Hotline Fluid Warming Set
The Hotline Fluid Warming Set may have an increased likelihood of leakage in specific lots.
Boston Scientific FARASTAR Ablation Generator and Cardiac Ablation Catheter
The Farastar Ablation Generator has a configuration not compatible with the Farapoint catheter.
1 recall
Tosoh ST AIA-Pack Testosterone Test
The test cup lot F level 1 low-quality control results were lower than expected, which could cause falsely elevated or falsely low total testosterone results.
2 recalls
Daavlin Photera Phototherapy Devices
The Photera 400 phototherapy device has incorrect UV sensor gain.
3 products
Papablic Replacement Brush Heads
Papablic Replacement Brush Heads have a potential to break.
2 products
1 recall
GE Optima XR200amx, XR220amx and XR240amx Radiographic Systems
This could result in patient injury during an exam.
3 products
2 recalls
Boston Scientific Rapid Refill Continuous Injection System
The Rapid Refill Continuous Injection System contains a syringe that may loosen or disconnect, causing fluid leakage or separation.
ICU Medical Plum Duo Infusion and Solo Precision IV Pump
The Plum Duo Infusion Pump may deliver up to twice the programmed volume in a specific scenario.
2 products
4 recalls
Think Surgical TMINI Femur and Tibia Tracking Arrays
The TMINI Femur and Tibia Tracking Arrays may loosen at the knob, causing misalignment.
Vitek 2 AST-N447 Test Kit
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
GSP Neonatal GALT Kit
The GSP Neonatal GALT Kit may have a stability issue that can delay patient results.
Elekta Brachytherapy Applicators
The Fletcher CT/MR Shielded Applicator Set can detach its intrauterine tube tip, which may remain within a patient.
3 products
4 recalls
KL Owen Custom Orthodontic Solution
The orthodontic solution has a product error defect that may cause incorrect bracket placement.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
The assay has a potential for intermittent well-to-well bias.
Medline Convenience Kits
Medline Convenience Kits contain temperature probes with an error in their distribution control process.
3 products
Fresenius Medical Care 5008X Blood Tubing Sets
5008X Blood Tubing Set may have connection issues that can cause online port errors.
2 products
1 recall
Olympus Single Use Distal Cover
The Olympus Single Use Distal Cover has a newly designed replacement version.
3 recalls
GORE TAG Thoracic Branch Endoprosthesis Side Branch Component
The GORE TAG Thoracic Branch Endoprosthesis Side Branch Component can separate from its catheter.
Solar GI System (Water Perfusion)
The Solar GI System can accumulate moisture inside its tubing or sensors, affecting airflow or pressure measurement.
Masimo Radius VSM ECG Sets and NIBP Cuffs
Radius VSM ECG pre-connected Set and Disposable NIBP Cuff may have issues that could delay treatment or cause skin irritation.
2 products
8 recalls
Siemens ARTIS Icono Ceiling
The ARTIS icono ceiling has a potential issue with the suspension that holds the monitor, and screws may loosen over time.
RaySearch RayCare Oncology Information Systems
Beam set delivery note issues can cause data loss if the note is modified simultaneously or updated during a treatment session.
2 products
Hillrom Volara Circuit Kits
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.
4 products
Medela ENFit Enteral Extension Sets
The ENFit ExSet Strl 60 2.0ml PV 1ct EN may have incorrect connectors, causing misconnection and delivery delays.
Siemens ARTIS Icono Biplane, Ceiling and Floor
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
3 products
Accuray CyberKnife Treatment Delivery System and Linear Accelerator
The Cyberknife system's collimator may not fully dock, triggering an interlock and preventing motion.
Hamilton Medical IntelliCuff Portable Automatic Cuff Pressure Controller
The IntelliCuff portable automatic cuff pressure controller may alarm with a leakage error and fail to maintain pressure.
Baxter Adapter for Head Positioning
The Adapter for Head Positioning may become loose and move during patient positioning.
2 recalls
Remel GC Agar Base
GC Agar Base may have reduced or no recovery of some strains of Neisseria gonorrhoeae.
Hamilton Medical Coaxial Breathing Circuit Sets
The coaxial breathing circuit may have expiratory valve membranes sticking, causing an exhalation obstructed alarm and inadequate ventilation.
2 recalls
Medline Convenience Kits
Medline Convenience Kits contain lidocaine ampules with quality issues that may affect their use.
15 products
Medacta Short Monobloc Stem Broaches
Short Monobloc Stem Broaches may increase the risk of fracture in the medial region of the proximal humerus.
2 recalls
Medline Convenience Kits Containing Recalled Swan-Ganz Catheters
Medline Convenience kits contain Swan-Ganz catheters with leaks or breakage that may lead to infection, medication loss, or blood loss.
8 products
Mentor Texas Syringes
Expired syringes were distributed due to a distribution system control failure.
2 recalls
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump
The Intera Oncology Intera 3000 Hepatic Artery Infusion Pump has potential for leakage along the drug pathway.
Abiomed Impella CP Sets and Low Profile Introducer Kits
Potential for thrombus formation during prolonged use of the introducer.
4 products
5 recalls
Persona Revision Trabecular Metal Femoral Distal Augment
The Persona Revision Trabecular Metal Femoral Distal Augment may contain a posterior augment inside its package.
Medline Convenience Kits
Medline Convenience Kits contain lidocaine and bupivacaine injections with quality issues.
4 products
GE Healthcare AW Server 3.2 ext.6.5
The AW Server may open the previous patient's exam instead of the intended one, potentially leading to misdiagnosis.
Surgify Halo Surgical Drills and Burrs
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
19 products
Stryker Neurovascular Inzone Detachment System
The INZONE DETACHMENT SYSTEM may experience premature battery drain, causing it to not power on or be unable to detach a coil.
3 recalls
Zimmer Off-Axis Comprehensive Shoulder System Reamer Guides
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
5 products
PFM Medical Multi-Snare Sets
The Multi-Snare Set failed to meet biocompatibility requirements, which could cause localized inflammation and tissue irritation.
Ventec Life Systems VOCSN+Pro Package
The VOCSN+Pro respiratory system may have a damaged backup battery, causing the backup alarm not to activate during power loss.
3 recalls
Philips Avalon Fetal Monitor
The Philips Avalon Fetal Monitor has incorrect speaker connector assembly that can cause loss of speaker output.
2 products