United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
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.
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7813...
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 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.
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.
Medline medical procedure kits, containing Medline Neuro Sponges (102 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.
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Num...
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 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.
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.
Heraeus, PALAMIX uno. Material Number: 66057893.
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).
Philips Evolution Upgrade 1.5T 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.
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.03...
Includes an incorrect screw seat interface.
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.
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, 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 LT SZ 4 CEM. Part Number: 150450104...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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.
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an...
Cyber vulnerability of BLE communication was found by CISA VDP program.
Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. ...
Product contains undeclared Yellow No. 5.
52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinki...
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
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.
KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 81881202220...
Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.