2012 Product Recalls
5,173 recalls issued in 2012.
Showing 5001–5020 of 5,173 recalls
Calcium Sulfate Hemihydrate 0.5 gram kits.
Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of adverse health consequences with the Fast Set 4% potassium sulfate solution include tissue inflammation and infection.
Ace Surgical has become aware through internal review of possibility sterility issues with one of the components included in the Calcium Hemihydrate 0.5 and 1.0 gram kits. Customers with questions should contact ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.
CUMMINS V-BAND CLAMPS
IF THE INLET OR OUTLET SECTIONS DISCONNECT, HOT EXHAUST GASES CAN VENT PRIOR TO EXITING THE TAILPIPE, CREATING THE RISK OF COMBUSTION AND A FIRE. IF BOTH CLAMPS FAIL, THERE IS A RISK IN SOME APPLICATIONS THAT THE DOC/DPF HOUSING MAY DETACH COMPLETELY, CREATING A ROAD HAZARD.
HME IS WORKING WITH CUMMINS TO IDENTIFY OWNERS. CUMMINS IS HANDLING THE OWNER NOTIFICATION AND REMEDY FOR THIS CAMPAIGN. PLEASE SEE NHTSA RECALL 11E-031. OWNERS MAY CONTACT CUMMINS AT 1-812-377-5000.
SHIFTER/FMVSS 114
THE OPERATOR CAN INADVERTENTLY SHIFT THE VEHICLE INTO GEAR WITHOUT THE BRAKE PEDAL BEING DEPRESSED, INCREASING THE RISK OF A CRASH OR INJURY TO A NEARBY PEDESTRIAN.
NISSAN WILL NOTIFY OWNERS, AND DEALERS WILL INSPECT AND REPLACE THE SHIFTER KNOB OR THE SHIFTER ASSEMBLY AS NEEDED, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MEARH 5, 2012. OWNERS MAY CONTACT NISSAN AT 1-800-647-7261.
SPLIT SERVICE BRAKE SYSTEM/FMVSS 122
WITHOUT THE REQUIRED BRAKE RESERVOIR LABEL, OPERATORS MAY IMPROPERLY MAINTAIN THE BRAKE SYSTEM. WITH ONLY A SINGLE BRAKE FLUID RESERVOIR FOR THE ENTIRE BRAKE SYSTEM AND NO BRAKE FAILURE INDICATOR LAMP, IN THE EVENT OF ANY BRAKE FLUID LEAK, THE ENTIRE BRAKE SYSTEM COULD FAIL WITHOUT WARNING, INCREASING THE RISK OF A CRASH.
WILDFIRE WILL CONTACT OWNERS, AND DEALERS WILL CORRECT THE MOTORCYCLES, FREE OF CHARGE. THE RECALL BEGAN ON APRIL 18, 2012. OWNERS MAY CONTACT WILDFIRE AT 1-740-283-6540.
DRIVER-SIDE OR PASSENGER-SIDE SIDE CURTAIN AIRBAG
IN THE EVENT OF A CRASH, THE SIDE CURTAIN AIRBAG MAY FAIL TO DEPLOY, INCREASING THE RISK OF INJURY.
HONDA WILL REPLACE THE DRIVER'S SIDE OR PASSENGER'S SIDE SIDE CURTAIN AIRBAG AS NEEDED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 24, 2012. OWNERS MAY CONTACT HONDA CUSTOMER SERVICE AT 1-800-999-1009.
CURTAIN SHIELD AIRBAG
IN THE EVENT OF A CRASH, THE AIRBAGS MAY NOT DEPLOY AND WILL NOT BE ABLE TO PROPERLY PROTECT AN OCCUPANT, INCREASING THE RISK OF INJURIES.
TOYOTA WILL NOTIFY OWNERS, AND DEALERS WILL CHECK THE VEHICLE IDENTIFICATION NUMBER TO IDENTIFY THE CURTAIN SHIELD ASSEMBLIES AND REPLACE THE ASSEMBLIES AS NECESSARY WITH NEW ONES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 8, 2012. OWNERS MAY CONTACT TOYOTA AT 1-800-331-4331.
ALUMINUM WHEEL/RIM
THIS SITUATION CAN RESULT IN THE WHEEL/RIM MOVING, SHEARING OF THE WHEEL STUDS AND THE WHEEL COMING OFF OF VEHICLE, INCREASING THE RISK OF A CRASH.
DRV WILL NOTIFY OWNERS, AND DEALERS WILL REMOVE THE PAINT FROM THE HUB FACE AND THE BACK OF THE WHEELS FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 5, 2012. OWNERS MAY CONTACT DRV AT 1-574-457-6472.
HYDRAULIC CONTROLS
IF THE LADDER UNEXPECTEDLY MOVES, THE OPERATOR CAN LOSE CONTROL OF THE BUCKET LOCATION, INCREASING THE RISK OF INJURY.
KME WILL NOTIFY OWNERS, AND DEALERS WILL REPAIR THE TRUCKS FREE OF CHARGE. THE SAFETY RECALL BEGAN ON APRIL 10, 2012. OWNERS MAY CONTACT KOVATCH MOBILE EQUIPMENT CORPORATION AT 1-570-669-5154.
BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135412
The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft.
The Bard Peripheral Vascular "URGENT MEDICAL DEVICE RECALL NOTIFICATION" with attached "RECALL AND EFFECTIVENESS CHECK FORM" was sent to the affected consignees beginning May 7, 2010 via FedEx. The recall notice informed the consignees of the reason for recall, the products affected and instructed them not to use or further distribute any affected product. The consignees were also instructed to call the firm's Recall Coordinator Silvia Carrillo at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at silvia.carrillo@crbard.com to facilitate the expedient return of the affected products. Additionally they were asked to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.
Holiday-themed tea light candle warmers Recalled for Fire Hazard
The candle warmers can catch fire because the warming bowl is positioned too close to the tea light candle, posing fire and burn hazards.
Consumers should immediately stop using the recalled tea light candle warmers and return them to any Christmas Tree Shops store to receive a full refund.
Lush Life® power strips Recalled for Fire Hazard
The power strips have undersized wiring, and the wiring and plastic strip fail to meet the requirements for fire resistance, posing a fire hazard.
Consumers should stop using the recalled power strips immediately and return them to any of The Container Store locations for a full refund plus a $15 merchandise card.
Hurricane Style Lights Recalled for Fire Hazard
An electrical short circuit can occur in the light's internal wiring, causing smoke and posing a fire hazard.
Consumers should immediately stop using the recalled product and return it to any Christmas Tree Shops location for a full refund.
FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures.
Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
Volcano Corporation sent recall letters dated October 6, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and fax the attached Customer Reply Letter so that an RMA could be issued for the return of the unused affected product, and any replacement or credit could be arranged. Customers were instructed to return the Customer Reply letter even if they no longer have the affected product in their inventory. For questions regarding the use of the product. customers were instructed to contact their Sales Representative. For questions regarding this recall call 916-281-2790.
SERVICE BRAKES/ANTILOCK TRACTION RELAY VALVE
UNEXPECTED CONTINUOUS BRAKE APPLICATION CAN CAUSE THE BRAKES TO OVERHEAT AND LEAD TO A FIRE. UNEXPECTED CONTINUOUS BRAKE APPLICATION CAN CAUSE THE DRIVER TO LOSE CONTROL OF THE VEHICLE, INCREASING THE RISK OF A CRASH. ALSO, THE BRAKES MAY BE APPLIED WITHOUT ILLUMINATING THE BRAKE LIGHTS, FAILING TO GIVE PROPER WARNING TO OTHER DRIVERS.
PACCAR WILL NOTIFY OWNERS, AND PROVIDE A TEMPORARY REPAIR UNTIL BENDIX DEVELOPS A PERMANENT REMEDY. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 10, 2012. OWNER MAY CONTACT KENWORTH AT 1-425-828-5440 AND PETERBILT AT 1-940-591-4196.
***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900*** For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.
Linvatec Corp. dba ConMed Linvatec sent an Urgent Medical Device Recall Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility's inventory for the affected product. If they had any of the product they were instructed not to use and segregate the product and return for credit. Return the affected products and the completed REPLY FORM to their local ConMed Linvatec office. If the product was transferred to another facility, customers were instructed to complete the REPLY FORM documenting the transfer of the product and mail or fax the REPLY FORM to their local ConMed Linvatec office at 727-319-5701. If the customers do not have the affected product they should complete the REPLY FORM and mail in the enclosed envelope or fax to 727-319-5701.
2012 Bicycles with Advanced Group carbon forks Recalled for Fall Hazard
The brake component housed within the bicycle's carbon fork can disengage from the fork and allow the brake assembly to contact the wheel spokes while rotating, posing a fall hazard.
Consumers should immediately stop riding these bicycles and return them to an authorized Specialized retailer for a free repair or replacement carbon fork.
Arctic Cat Snowmobiles Recalled for Crash Hazard
The lower steering tie-rod attachment can loosen and cause loss of steering control, posing a crash hazard.
Consumers should immediately stop using these snowmobiles and contact their local Arctic Cat snowmobile dealer to schedule a free inspection and repair. Arctic Cat has notified owners of these snowmobiles directly by mail.
Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes
Biomet Microfixation, Jacksonville, FL, sent an Urgent Medical Device Safety Alert letter dated November 8, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to fill out the attached Inventory Reconciliation sheet and FAX to 904-741-9425. If consignees further distributed this product, they must notify the recipient of this action by providing the recipient a copy of the notice. For questions call 800-874-7711 or 904-741-4400, ext 468.
Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a higher standby current resulting in the battery depleting prematurely.
Carefusion sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. A Customer Reply Card was enclosed for customers to complete and return to the firm. Customers were instructed to call Carefusion Support Center at (888) 562-6018, 7 am-5 pm (Pacific) for any recall related questions.
Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.