United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Philips Ingenia Ambition X 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.
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.
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma...
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
AIDBAGs are first aid kits of convenience composed of individually labeled devic...
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7812...
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.
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and ...
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mc...
cGMP deviations.
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alc...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 ...
cGMP deviations.
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 7...
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 Ingenia Elition X 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.
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in...
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total)...
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.
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL...
cGMP deviations.
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous De...
Includes an incorrect screw seat interface.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Heraeus, PALAMIX duo. Material Number: 66057897.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 m...
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, lab...
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.
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per m...
cGMP deviations.