Medical Devices Recalls

Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.

Products in this lot may have compromised barrier seals, introducing a risk to sterility.

It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system breach, which presents the possibility of cross-contamination where the potential contaminations are well known API's at well below efficacious dose levels.

Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.

The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.

Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.

Firm discovered a firmware memory leak with a supplier-manufactured component.

There is a potential that the proximal marker may separate from the imaging catheter

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.