Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP10...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS98...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF)...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF)...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, l...
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. ...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Brand Name: Leksell Vantage Arc System REF: 1053958
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
i-STAT G3+ cartridge; List Number: 03P78-26;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409...
There is a possibility of reagent leakage from the specimen container.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.