2015 Product Recalls

7,426 recalls issued in 2015.

7,426
Total Recalls
157
USDA
305
CPSC
2,020
FDA Drug
USDA 157 CPSC 305 FDA Drug 2,020 FDA Device 1,140 NHTSA 970 FDA Food 2,834

Showing 7421–7426 of 7,426 recalls

USDA Class I

Pennsylvania Firm Recalls Chili Product Due To Misbranding and an Undeclared Allergen

Misbranding
FDA

Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel.

The firm, B. Braun Medical Inc., sent an "URGENT: FIELD CORRECTION" letter dated September 8, 2011 to its customers. The letter described the product, problem and actions to be taken. The firm informed the customers that a B. Braun representative will be contact ing them to schedule a field software upgrade of the affected pumps. The customers were instructed to complete and return the FIELD CORRECTION INFORMATION FORM via mail using the enclosed envelop and contact B. Braun Customer Service for shipping instructions at 1-800-627-7867 if product is to be returned. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Technical Product Support at 1-800-627-7867 (800-627-PUMP).
FDA

The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.

Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.

Alcon sent an "URGENT: MEDICAL DEVICE REMOVAL" letter on April 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Alcon Sales Representative for questions regarding this notice.
NHTSA

Front Brake Hose may Rub on Tire

The rubbing may wear a hole into the brake hose resulting in a loss of air pressure in the front brake chamber, reducing brake performance and increasing the risk of a crash.

MCI will notify owners. The remedy for this recall is still under development. The recall began on March 2, 2015. Owners may contact MCI customer service at 1-800-241-2947.
FDA

SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.

SteriGear, LLC sent a special note to all affected customers between January 12, 2011 and September 28, 2012. The note identified the product, the problem, and the action to be taken by the customer. Customers were instructed on how to reposition the inlet tube. Customers with questions were instructed to contact Director of Product Development at 801-607-3211. No correction or removal was performed. For questions regarding this recall call 801-607-3209.
USDA Class I

Texas Firm Recalls Lamb Products Imported Without Benefit of Inspection

Import Violation