United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
iLet Bionic Pancreas, REF: BB1001
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Medline medical procedure kits, containing Medline Neuro Sponges (961 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.
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.
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.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg...
cGMP deviations.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per...
cGMP deviations.
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 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.
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.
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i...
Labeling: Missing Label
Corp. Micro Bird, Inc. - Contact with Drive Belt Pully May Damage and Cause Oil ...
A damaged oil like may leak, increasing the risk of a fire in the presence of an ignition source.
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
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 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.
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 (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.
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (...
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.
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, M...
Lack of Assurance of Sterility