Abbott Diagnostics Scarborough ID NOW Influenza A & B 2
The ID NOW Influenza A & B 2 has a higher occurrence of invalid rates.
Medical device recalls
Medical device recalls from FDA, newest first.
1 recall
3 recalls
Medline Open Heart, Cardiac Procedure and Cardio Congenito Kits
The chest drainage units have updated instructions to clarify they are for adults only.
Medline Medcrest Surgical Gowns and Surgical Drapes
Medline Medcrest Surgical Gowns may experience premature delamination, which can cause brief delays in patient care and risk of infection.
2 products
Lutronic CLARITY II Laser System
The Clarity II Laser System can spark or pop and potentially burn patients.
1 recall
HealthCast "Vital Sync" Remote Patient Monitoring System
Alarms from the primary patient bedside monitor may not be transmitted or received on the remote system.
4 recalls
Waldemar Link Endo-Model Replacement Plateaus and Connection Components
Endo-Model Replacement Plateau and SL Connection Components may have a bushing that detaches from the screw shaft.
13 products
GEM Premier 5000
GEM Premier 5000 PAK may experience increased Process Control Solution Not Detected errors during warm-up, causing ejection and delays.
20 products
Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes
Infant/Child Reduced Energy Defibrillator Electrodes may delaminate, which can affect defibrillation.
Medartis APTUS TriLock Screws
APTUS TriLock Screws may be mixed up between specified lots of 2.5mm and 2.8mm outer diameter screws.
2 products
1 recall
Exactech Equinoxe Ergo and Equinoxe Core Instrument Kits
The Equinoxe Core Instrument Kit and Ergo Modular Impactor Handle may have a missing cross-pin in the impactor handle.
2 products
3 recalls
Raz Mobile Shower Commode Chairs
Mobile shower commode chairs may be reinstalled without properly engaging the outside rear seat brackets that keep the seat in place.
BD 10mL Luer-Lok Tip Syringes
The syringe may contain Luer Slip syringes instead of Luer Lok.
IBA Proton Therapy System - PROTEUS 235
The IBA Proton Therapy System - PROTEUS 235 has a disabled beam triggering interface, which may lead to mistreatment.
1 recall
Olympus ShockPulse-SE Lithotripsy System with Generator
The Olympus ShockPulse-SE Lithotripsy System has a mis-wired component that can cause noise and delay treatment.
2 recalls
Datascope CS100 and CS300 Intra-Aortic Balloon Pumps
The CS100 Iabp and CS300 Iabp have battery runtime and cycle specifications that need to be updated.
2 productsSTA Liatest Free Protein S
The STA Liatest Free Protein S kit may show out-of-range results and underestimate free protein S levels in normal plasma.
3 recalls
B. Braun 21G Winged Infusion Sets
B. Braun winged infusion sets may have a dull or blunt needle tip that can be difficult to advance or break.
3 productsAesculap MINOP Trocar
The Minop Trocar 150MM 4 Wking CHANNEL6.0MM may have a trocar shaft that is too long.
Atellica CH Urine Albumin (UAlb)
Atellica CH Urine Albumin may report falsely depressed results for samples above 40.0 mg/dL.
2 recalls
Impella RP
The Impella RP devices have a sensor that may malfunction, causing sensor values to drift.
3 products
GE Healthcare Centricity Universal Viewer Zero Footprint Client
The viewer may show patient information that does not match the images displayed.
2 recalls
Remel Campy CVA Medium
Campy CVA Medium may have low recovery of Campylobacter Jejuni.
Agiliti Adapt Pump
The Adapt Pump may not re-engage the Microclimate Management function after using Autofirm for 10 minutes.
1 recall
Spectrum IQ Infusion Pump
The Spectrum IQ Infusion Pump was released without full testing, including occlusion alarm testing.
3 recalls
Philips Azurion Systems
Azurion systems may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.
8 productsLaerdal Compact Suction Unit 4 RTCA Version
The Laerdal Compact Suction Unit 4 RTCA version may emit electromagnetic noise beyond acceptable limits.
ATEC Lateral Navigation Disc Prep Instruments
ATEC Lateral Navigation Disc Prep Instruments have a design issue with incorrect navigated array connection geometry.
2 products
1 recall
Straumann WB Impression Post Closed Tray
The impression post closed tray contains magenta caps instead of brown.
1 recall
Philips Brilliance iCT and Spectral CT Scanners
Spectral CT 7500 on Rails may have fasteners not torqued to specification, potentially causing rotor parts to become unsecured and expelled.
4 products
3 recalls
Olympus Sphincterotomes
Single Use 3-Lumen Sphincterotome V devices may deform and lose performance.
30 products
Maquet Cardiopulmonary Bubble Sensor
The Bubble Sensor has a durability issue with its connecting cable that can cause damage or loose contact.
FUJIFILM FDR Visionary Suite
The FDR Visionary Suite X-ray high-voltage generator can overheat and damage surrounding parts, possibly causing smoke.
2 recalls
VITEK 2 Gram-negative Susceptibility Cards
Issue may lead to QC failure or false resistant results.
Vantive Prismaflex and Oxiris Dialyzer Sets
The Prismaflex Set deaeration chamber may dislodge from the Control Unit.
8 products