2012 Product Recalls
5,173 recalls issued in 2012.
Showing 5141–5160 of 5,173 recalls
TIRE PRESSURE MONITOR SYSTEM/FMVSS 138
UNDERINFLATED TIRES CAN RESULT IN TIRE OVERLOADING AND OVERHEATING, WHICH COULD LEAD TO A BLOWOUT AND POSSIBLE CRASH.
CHRYSLER WILL NOTIFY OWNERS AND DEALERS WILL REPROGRAM THE VEHICLES TPMS. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 2, 2012. OWNERS MAY CONTACT CHRYSLER AT 1-800-853-1403.
Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;
Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.
On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.
Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.
The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.
Pentron Clinical sent an URGENT: Medical Device Recall letter dated April 20, 2011 to all affected customers. The letter described the product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine all product(s) subject to recall for return and exchange at no charge. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were also asked to complete and return the enclosed Recall Return Form. Contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangement of a quick return and replacement.
ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203
Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).
The firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690.
GE Healthcare Definium 8000 Digital Radiographic System.
Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs rea
GE sent a Product Safety Notification dated March 7, 2008 to all customers. The letter described the safety issue, affected product, and stated that a GE Healthcare Field Engineer will schedule a field visit to install software updates.
Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX. Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in cereb
Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile barrier in the packaging may be compromised. During internal inspections, they discovered gaps between the side seals and the top seal approximately 3/8 in len
Boston Scientific issued an "Urgent Medical Device Recall Removal" letter dated August 5, 2009. The letter was addressed to Risk Manger / Field Action Contact. The letter described the problem and product involved. The Firm recommended to segregate affected product immediately and return to Boston Scientific and requested return of the "The Reply Verification Tracking Form" enclosed with the letter. For further questions, contact your local Boston Scientific Sales Representative or call 1-763-494-1634.
GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.
The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
GE Field Engineers will visit affected customers to make correction.
Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico.
Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect product sterility.
Consignees were sent a Medtronic "Important Medical Device Recall" Letter dated February 2010 on 2/25/10. The letter described the problem and the product. Medtronic recommended to immediately remove the affected leads from inventory. Customers with questions, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-505-4636.
Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced.
Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. There have been 41 complaints in the US as
Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated March 11, 2009. The letter was addressed to Risk Manager/Field Action Contacts describing the problem including instructions for affected device handling and a request to return the enclosed Reply Verification Tracking Form. Further questions can be addressed to Boston Scientific at 763-494-1634.
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired with off-center collimation for extremities with the position selected as Digits to front or Digits to back are displayed as blank. Investigation into th
Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, Corrective Action and Contact Information.
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnost
GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equival
Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
EVAPORATOR ASSEMBLIES/POSSIBLE FIRE
IF SUFFICIENT ARCING OCCURS, THE FUSE HOLDER MAY MELT, AND MAY BE ACCOMPANIED BY FLAME, SMOKE AND POTENTIAL FIRE.
ELKHART WILL NOTIFY OWNERS AND PROVIDE INFORMATION ON HOW TO OBTAIN THE RETROFIT KIT FROM CARRIER ALONG WITH REPAIR INSTRUCTIONS. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 5, 2012. (SEE CARRIER'S RECALL CAMPAIGN 11E-003.) OWNERS MAY CONTACT CARRIER AT 1-800-348-7440.
Bicycle helmets for children and youth Recalled for Fall Hazard
Product testing demonstrated that these helmets do not comply with CPSC safety standards for impact resistance. Consumers could suffer impact head injuries in a fall.
Consumers should stop using the product immediately and contact Triple Eight for a full refund.
INSTRUMENT CLUSTER SOFTWARE/PARKER
ENGINE SHUTDOWN WOULD RESULT IN LOSS OF VEHICLE PROPULSION OR VEHICLE STALL, EITHER OF WHICH INCREASES THE RISK OF A CRASH.
NEW FLYER WILL REPROGRAM THE INSTRUMENT PANEL FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 9, 2012. NEW FLYER WILL UPLOAD A CORRECTED SOFTWARE VERSION FREE OF CHARGE. OWNERS MAY CONTACT NEW FLYER AT 1-204-934-4876.
OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels
Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.
Lifescan sent an Urgent Medical Device Correction letter dated May 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told that no action on their part is needed and were asked not to return any of the affected product. Customers were instructed to continue to distribute the product. Healthcare professionals and pharmacies were asked to share the information with their patients who use the OneTouch Delica Lancing Device. Patients with questions should contact Customer Care Line at 1-800-574-6138. For questions regarding this recall call 1-800-600-7226.
6-pc. LED Flashlight Sets Recalled for Fire Hazard
When turned on, the flashlights can heat up, smoke or melt, posing fire and burn hazards.
Consumers should immediately stop using the flashlights and return them to any Target store for a full refund.
Children's Chairs and Stools Recalled for Poisoning Hazard
The yellow surface paint on the metal frame of the children's chairs and stools contains excessive levels of lead which is prohibited under federal law.
Consumers should immediately take the recalled tables and folding chairs away from children and return them to any 1 to Seven store in Puerto Rico or contact Elegant Gifts Mart for a full refund.
ANTILOP High Chairs Recalled for Fall Hazard
he high chair's restraint buckle can open unexpectedly, posing a fall hazard to the child
Consumers should immediately stop using the high chairs and contact IKEA to obtain a free replacement seat restraint.
5 Hour Tea Lights Recalled for Fire Hazard
The tea light wax can overheat resulting in the wax catching fire, posing a burn and fire hazard.
Stop using these candles immediately and return any unused candles to the place of purchase for a full refund. Food service distributors and restaurant supply stores have been directly notified about this recall by mail.
ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.
Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
A - M Systems sent a Urgent Notification of Product Recall/Correction dated March 31, 2010, to all affected customers. The letter identificed the product the problem and the action needed to be taken by the customer. Customers were instructed to cease use and/or distribution of the affected product and to immediately notify any of their sub-accounts with the same information. Customers are asked to provide A - M Systems with the amount distributed and amount remaining in inventory and to then destroy or discard any remaining product in their possession. Please call 360.683.8300, if you have any questions or concerns.