Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
All Recalls
92,900 total recalls in our database
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
Boston Scientific
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Alaris PC Unit, Model 8015
CareFusion 303
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Logic Fit Tibial Tamp Head
Exactech
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
Exercise machines
Core Health & Fitness, of Vancouver, Wash.
The height adjusting carriage assembly can loosen and fall on the consumer, posing an impact hazard.
TriggerTech Carbide crossbow and rifle triggers
TriggerTech, of Mississauga, Canada
Rollers on the triggers can crack causing the weapon to discharge without trigger activation, posing an injury hazard to the user or bystander.
Electric bicycle conversion Copenhagen wheels
Superpedestrian Inc., of Cambridge, Mass.
The rear axle can fail, posing fall and crash hazards to riders.
Cub Cadet 2016 Challenger utility vehicles
Hisun Motors Corp. U.S.A., of McKinney, Texas
Air in the brake system can cause brake failure, posing a crash hazard to the user or bystander.
Mr. Hyde Blue Razz (V2)
ProSupps USA
Product is potentially mislabeled and contains the non-dietary ingredient Picamilon.
Product contains undeclared tree nuts-cashews
Mr. Hyde Watermelon (V2); Mr. Hyde 30 Watermelon
ProSupps USA
Product is potentially mislabeled and contains the non-dietary ingredient Picamilon.
Dr. Jekyll V2 Orange Burst domestic
ProSupps USA
Product is potentially mislabeled and contains the non-dietary ingredient Picamilon.
Dr. Jekyll V2 Watermelon domestic
ProSupps USA
Product is potentially mislabeled and contains the non-dietary ingredient Picamilon.
Product is potentially mislabeled and contains the non-dietary ingredient Picamilon.
Ava's brand Organic Cashews Roasted & Salted 8 oz. tubs, UPC 8-10111-01035-1
Severn Peanut Co., Inc.
Product may be contaminated with Listeria monocytogenes.
BAKEHOUSE BREAD ARTISAN CRANBERRY ORANGE BREAD, 16 OZ UPC 8 64934 00004 4 Bakehouse Bread Company Tucson, AZ
Kroger Corporate Food Technology Laboratory
The firm was notified by a customer that the label does not include Pecans or Tree Nuts in the Allergy contain statement.
Firm is recalling a limited number of Green Tea and Red Bean ice cream due the possibility of the presence of metal fragments.