2009 Product Recalls

1,443 recalls issued in 2009.

1,443
Total Recalls
383
CPSC
490
FDA Device
570
NHTSA
CPSC 383 FDA Device 490 NHTSA 570

Showing 1–20 of 1,443 recalls

NHTSA

AFTERMARKET SERVICE BRAKE/AIR DRUMS

PREMATURE WEAR OF THE BRAKE DRUM WOULD DECREASE EFFECTIVE BRAKING ABILITY, INCREASING THE RISK OF A VEHICLE CRASH.

CHINADA WILL NOTIFY OWNERS OF RECORD AND THE AFFECTED BRAKE DRUMS WILL BE REPLACED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON DECEMBER 11, 2009. OWNERS MAY CONTACT CHINADA AT 1-905-670-2300.

FDA

Stryker Instruments Navigation System II- CART, Stryker Navigation, Kalamazoo, MI; Stryker REF 7700-100-000. Intended to be used as a component of the Navigation System II.

Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.

The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.

FDA

Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00101. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.

Lack of assurance of sterility.

The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and instructed to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08.

FDA

Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder CHT620.

Lack of assurance of sterility, as the package seals may be inadequate.

Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.

FDA

Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.

Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. For further information, please contact Hill-Rom, Inc. at 800-445-3720.

Consignees were notified of the problem by letter dated 11/11/08 and instructed to position the bed at least 3 inches above the lowest bed position in order to prevent the problem, and then to only use the pendant electronic controls to raise and lower the head and foot sections of the bed, until Hill-Rom can repair the bed. The letter was entitled "Urgent Medical Device Correction."

NHTSA

AFTERMARKET HEATED CAR BLANKET/OVERHEATING

OVERHEATING OF THE BLANKET CAN RESULT IN SKIN BURNS OR POSSIBLY A FIRE.

MILES KIMBALL HAS NOTIFIED OWNERS OF RECORD AND IS OFFERING A FULL REFUND. THE SAFETY RECALL BEGAN ON DECEMBER 17, 2009. OWNERS MAY CONTACT MILES KIMBALL COMPANY RETURN'S DEPARTMENT AT 1-800-255-4590.

NHTSA

SEAT SWIVEL/FMVSS 207 & 210

THIS DOES NOT MEET THE REQUIREMENTS OF THE STANDARD.

DEALERS WILL REMOVE THE SWIVEL AND INSTALL A NEW DESIGN OF SWIVEL THAT DOES NOT REQUIRE A REINFORCING PLATE IN ORDER TO MEET THE STANDARD. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 15, 2010. OWNERS MAY CONTACT WINNEBAGO AT 1-800-537-1885.

NHTSA

CHARCOAL CANISTER VENTILATION HOSE

WATER COULD FLOW INTO THE CANISTER CAUSING A STALLING CONDITION INCREASING THE RISK OF A CRASH.

DEALERS WILL INSPECT AND ADD AN ADDITIONAL HOSE AND ROUTE IT SUCH THAT THE PRESENT DEFECT IS PREVENTED. THIS REMEDY WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MAY 13, 2010. OWNERS MAY CONTACT BMW AT 1-800-831-1117.

NHTSA

ADJUSTABLE BRAKE PEDAL ASSEMBLIES

IF THE DRIVE PIN BECOMES DISENGAGED ON THE BRAKE PEDAL ASSEMBLY, IT COULD RESULT IN A LOSS OF VEHICLE BRAKING FUNCTION AND/OR CAUSE THE BRAKE PEDAL TO INTERFERE WITH THE THROTTLE PEDAL FUNCTION. EITHER CONDITION COULD RESULT IN A VEHICLE CRASH.

FORETRAVEL IS WORKING WITH KONGSBERG TO REMEDY THESE MOTORHOMES. PLEASE SEE KONGSBERG'S DEFECT REPORT 09E-064. THE REMEDY WILL BE PERFORMED BY FORETRAVEL FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING JANUARY 2010. OWNERS MAY CONTACT FORETRAVEL AT 1-800-955-6226.

NHTSA

SEAT BELT TENSION SENSOR WIRING HARNESS

THE SEAT OCCUPANT IS AT AN INCREASED RISK OF INJURY SHOULD THE AIR BAG NOT DEPLOY AS INTENDED.

HYUNDAI WILL NOTIFY OWNERS AND REPAIR THE VEHICLES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 22, 2010. OWNERS MAY CONTACT HYUNDAI CUSTOMER ASSISTANCE CENTER AT 1-800-633-5151.

CPSC

Wooden Skill Ball Toys Recalled for Poisoning Hazard

The surface paint coating on the ball contains excessive levels of lead, violating the federal lead paint standard.

Consumers should immediately take the recalled toys away from children and contact Kendamaspot to receive a free replacement ball.

CPSC

Safety 1st Disney Care Center™ Play Yard and Eddie Baue Recalled for Suffocation Hazard

The one piece metal bars supporting the floorboard of the bassinet attachment can come out of the fabric sleeves and create an uneven sleeping surface, posing a risk of suffocation or positional asphyxiation.

Consumers should immediately stop using the bassinet attachment to the play yard and contact Dorel Juvenile Group for a free repair kit including replacement bassinet fabric, bassinet bars and installation instructions.

CPSC

Portable Dehumidifiers Recalled for Fire Hazard

The power connector for the dehumidifier's compressor can short circuit, posing fire and burn hazards to consumers.

Consumers should immediately stop using the recalled dehumidifier, contact LG to determine if it is included in the recall and return it to an authorized LG service center for a free repair.

NHTSA

ADJUSTABLE BRAKE PEDAL ASSEMBLIES

IF THE DRIVE PIN BECOMES DISENGAGED ON THE BRAKE PEDAL ASSEMBLY, IT COULD RESULT IN A LOSS OF VEHICLE BRAKING FUNCTION AND/OR CAUSE THE BRAKE PEDAL TO INTERFERE WITH THE THROTTLE PEDAL FUNCTION. EITHER CONDITION COULD RESULT IN A VEHICLE CRASH.

TIFFIN IS WORKING WITH KONGSBERG TO REMEDY THESE MOTORHOMES. PLEASE SEE KONGSBERG'S DEFECT REPORT 09E-064. KONGSBERG WILL SUPPLY KITS TO TIFFIN. THE REMEDY WILL BE PERFORMED BY TIFFIN FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 19, 2010. OWNERS MAY CONTACT TIFFIN AT 1-256-356-8661.

NHTSA

HORIZON LED SIDE DESTINATION SIGN/POSSIBLE FIRE

THE CORROSION COULD CAUSE AN ELECTRICAL SHORT THAT COULD RESULT IN A FIRE.

NABI WILL NOTIFY OWNERS AND LUMINATOR WILL REPAIR THE BUSES FREE OF CHARGE. PLEASE SEE LUMINATOR'S DEFECT REPORT 09E-054. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING JANUARY 2010. OWNERS MAY CONTACT LUMINATOR AT 1-972-516-3033 OR NABI AT 1-256-831-4296.

NHTSA

REMOTE RELEASE BELT RETRACTORS

IF THE BELT DOES NOT LOCK AND THE MOBILITY DEVICE IS NOT PROPERLY RESTRAINED, THERE IS AN INCREASED RISK OF INJURY TO THE PASSENGER IN THE EVENT OF A CRASH.

NOVA BUS IS WORKING WITH AMERICAN SEATING AND WILL REPLACE THE Q'STRAINT MAX REMOTE RELEASE BELTS WITH Q'STRAINT QRT DELUXE REMOTE RELEASE BELTS FREE OF CHARGE. AMERICAN SEATING IS HANDLING THE REMEDY FOR THIS CAMPAIGN. PLEASE SEE AMERICAN SEATING'S DEFECT REPORT 09E-065. THE SAFETY RECALL BEGAN ON DECEMBER 4, 2010. OWNERS MAY CONTACT AMERICAN SEATING'S SERVICE MANAGER SHERRY AELLEN AT 1-616-732-6484 AND NOVA BUS AT 1-450-472-6410.

NHTSA

REMOTE RELEASE BELT RETRACTORS

IF THE BELT DOES NOT LOCK AND THE MOBILITY DEVICE IS NOT PROPERLY RESTRAINED, THERE IS AN INCREASED RISK OF INJURY TO THE PASSENGER IN THE EVENT OF A CRASH.

GILLIG IS WORKING WITH AMERICAN SEATING AND WILL REPLACE THE Q'STRAINT MAX REMOTE RELEASE BELTS WITH Q'STRAINT QRT DELUXE REMOTE RELEASE BELTS FREE OF CHARGE. AMERICAN SEATING IS HANDLING THE REMEDY FOR THIS CAMPAIGN. PLEASE SEE AMERICAN SEATING'S DEFECT REPORT 09E-065. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR BEFORE JANUARY 29, 2010. OWNERS MAY CONTACT AMERICAN SEATING'S SERVICE MANAGER SHERRY AELLEN AT 1-616-732-6484 AND GILLIG AT 1-800-735-1500.

NHTSA

SIDEWALL MARKINGS/OMITTED FULL OR PARTIAL TIN

THE LACK OF A TIN ON BOTH SIDES OF THE TIRE COULD MAKE IT MORE DIFFICULT FOR CONSUMERS TO IDENTIFY THESE TIRES IF, IN THE FUTURE, A SAFETY-RELATED PERFORMANCE ISSUE WERE TO BE DISCOVERED. AS A CONSEQUENCE, THERE IS A RISK THAT THE TIRES WOULD NOT BE REMOVED FROM SERVICE, WHICH, IN TURN, COULD INCREASE THE RISK OF A VEHICLE CRASH.

THE SAFETY RECALLBEGAN ON APRIL 24, 2012. OWNERS MAY CONTACT YOKOHAMA CAMPAIGN SERVICE CENTER AT 1-888-801-4162.

FDA

Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital stretcher consisting of a platform mounted on a wheeled frame, designed to transport patients and to allow for patient care before, during and after transport.

The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is raised, increasing the possibility of the head section to become jammed and preventing it from lowering. This may result in a delay to the procedure.

Consignees will be visited to correct the problem and notified via a hand delivered Device Modification letter dated 4/3/08 at the time of the visit. If you have any questions please contact Jeffrey C. Shaul, Director, RA/QA Acute Care at (812) 931-2604.

FDA

Tri-State Centurion Endoscopy Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder MNS4635.

Compromised sterility, as the package seals may be inadequate.

A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.