2017 Product Recalls
7,025 recalls issued in 2017.
Showing 1–20 of 7,025 recalls
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to s
Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
The firm Medtronic, sent an "Urgent medical Device Safety Notification" dated November 2012, to its customers beginning November 09, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to follow the recommendations provided in the letter and complete and return the PHYSICIAN REPLY FORM via mail at Medtronic Neuromodulation Quality Assurance, 7000 Central Ave NE, Mailstop RCC150, Minneapolis, MN 55432; fax to: 800-897-3899 or email to: neuro.quality@medtronic.com. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST. UPDATE 2/1/2016: Medtronic began notifying consignees 2/1/2016 via, mail, telephone and/or in person visit by a Medtronic Field Representative. The Medtronic Field Representatives will retrieve devices in the US and provide an Urgent Medical Device Removal letter. The letter states that device design has been updated and the Medtronic Field Representative has retrieved any devices with a Use By date on or before 5/14/2017. An account specific Customer Confirmation Form was to be completed by either the Medtronic Field Representative or the consignee. Consignees with questions can contatct their Medtronic Field Representative, or Customer Service at 1-888-854-0978.
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
Beckman Coulter sent an Urgent Medical Device Recall letter dated April 24, 2017, to affected customers to inform them that Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. Internal testing has confirmed that MA is recovering within the published insert range for Beckman Coulter Urine Protein Control Level 2. Customers are informed of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to Customer Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada, and outside US and Canada they are instructed to contact their local Beckman Coulter Representative.
Fire Extinguisher May Be Clogged or Inoperable
In the event of a fire, if the fire extinguisher does not function properly, it can increase the risk of injury.
ShowHauler will notify owners to contact Kidde for a replacement fire extinguisher, free of charge. The recall began on February 28, 2018. Owners may contact Kidde customer service toll-free at 1-855-262-3540, or online at www.kidde.com and click on "Product Safety Recall" for more information or owners may call ShowHauler customer service at 1-574-825-6764.
Hydraulic Brake Fluid Leak
A brake fluid leak or air ingestion can lengthen the distance needed to stop the vehicle, increasing the risk of a crash.
Forest River will notify owners, and Ford or Lincoln dealers will inspect the HECU for missing valve block ball plugs, replacing the unit as necessary, free of charge. The recall began on January 26, 2018. Owners may contact Ford customer service at 1-866-436-7332 or Forest River customer service at 1-574-206-7600. Forest River's number for this recall is 68-0606.
Insufficiently Tightened Power Cable
The power cable and fuse box can overheat, increasing the risk of a fire.
Volvo will notify owners, and dealers will inspect the fuse box for damage, and replace it if necessary, as well as replace and tighten the nuts attaching the power cable, free of charge. The recall began February 2, 2018. Owners may contact Volvo customer service at 1-866-870-2046. Volvo's number for this recall is SR17-85.
Missing Heat Shield Between LP Tank and Exhaust
The missing heat shield can increase the risk of a fire.
TMC has notified owners, and dealers will install the missing heat shield, free of charge. The recall began on January 12, 2018. Owners may contact TMC customer service at 1-877-855-2867. TMC's number for this recall is RC000150.
Hydraulic Brake Fluid Leak
A brake fluid leak or air ingestion can lengthen the distance needed to stop the vehicle, increasing the risk of a crash.
Newmar will notify owners, and Ford or Lincoln dealers will inspect the HECU for missing valve block ball plugs, replacing the unit as necessary, free of charge. The recall began on January 24, 2018. Owners may contact Ford customer service at 1-866-436-7332 or Newmar customer service at 1-800-731-8300. Newmar's number for this recall is 17V-768.
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.
The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.
GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated Nov 20, 2012 to all affected customers. The letter described the product, problems and actions to be taken. The customers were instructed to follow the safety instructions and to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #86071. Customers were instructed to contact their GE Service Representative with any questions regarding this issue. For other questions, contact GE Helpdesk: North America; (905) 479-1249 or 1-888-778-3375; email: tgg.nahelpdesk@med.ge.com Europe; +44 1603 877595; email: tgg.ukhelpdesk@med.ge.com Asia Pacific; +61 3 5327 4000; email: tgg.ozhelpdesk@med.ge.com. For questions regarding this recall call 847-277-5000.
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Baxter Healthcare Corp. sent an Urgent Product Recall letter dated September 7, 2012, via first class mail to all affected customers, informing them of the problem with the ball-valve, and instructing them to discontinue use of the affected product and to contact Baxter for instructions to return the affected product.. The customers were also requested to complete the attached customer reply form, confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303.
Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu
Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
MidMark sent an Urgent Medical Device Field Correction letter dated September 4, 2014, to all affected customers. The letter included instructions for distributors to: 1) encourage end users to contact Midmark to arrange the field correction after the final solution becomes available; 2) if a partial image is reported to have occurred with a machine, the machine should be removed from use and the end user should initiate a service request per the normal procedure; 3) quarantine any affected machines in the distributor's inventory and contact Midmark Technical Support within 10 business days to provide the Serial numbers to on-site servicing of the affected machines can be scheduled. Distributors with questions about this market action can contact Midmark Technical Support by calling 888-294-3800 x 3 or by e-mail at imagingtechnsupport@midmark.com.
8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZX8416-10 For use to control bleeding and absorb fluid.
The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
International Medsurg Connection notified their direct accounts via telephone, e-mail and/or fax on April 9, 2012, informing them of the foreign material contamination of the gauze, and requesting them to quarantine all affected lots in inventory, cease distribution of the affected product, and notify any customers at the retail level to remove and discard these products. Any questions were directed to (847) 619-9926.
Incorrectly Installed 110V and 12V Wires
Pinched wires may short circuit, increasing the risk of a fire.
Forest River will notify owners, and dealers will inspect the trailers, rerouting the wires, as necessary, free of charge. The recall began on February 7, 2018. Owners may contact Forest River customer service at 1-541-644-8072. Forest River's number for this recall is 64-0456.
Caliper Bolts Improperly Torqued
If the caliper bolts are improperly torqued and the caliper detaches from the mounting flange, a loss of braking ability would occur, increasing the risk of a crash.
Hyundai Translead will notify owners, and dealers will inspect the bolts, replacing any loose or missing ones, free of charge. The recall began on January 19, 2018. Owners may contact Hyundai Translead customer service at 1-819-574-1500 or Meritor at 1-866-668-7221. Hyundai Translead's number for this recall is 17E049.
Fire Extinguisher May Be Clogged or Inoperable
In the event of a fire, if the fire extinguisher does not function properly, it can increase the risk of injury.
Tiffin will notify owners, and instruct them to contact Kidde for a replacement fire extinguisher, free of charge. The recall began on February 5, 2018. Owners may contact Kidde customer service toll-free at 1-855-262-3540, or online at www.kidde.com and click on "Product Safety Recall" for more information. Owners may also contact Tiffin customer service at 1-256-356-8661.
Unintended Vehicle Movement/FMVSS 102
If the transmission is not in neutral when the engine begins running, there may be unintended vehicle movement, increasing the risk of a crash.
PACCAR will notify owners, and dealers will update the TCM software, free of charge. The recall began February 6, 2018. Owners may contact Peterbilt customer service at 1-940-591-4000, or Kenworth customer service at 1-425-828-5000. PACCAR's numbers for this recall are 1217F and 1717KWF.
Front Brake Master Cylinder Failure
If the front brake master cylinder fails, the loss of front braking ability can increase the risk of a crash.
MV Agusta will notify owners, and dealers will replace the front brake master cylinder piston, free of charge. The began on January 19, 2018. Owners may contact MV Agusta customer service at 1-215-781-1770. MV Agusta's number for this recall is 18RC01.
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
Medtronic sent an Urgent : Field Safety Corrective Action dated April 13, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com, or fax to 763-367-8134. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact our Post-Market Quality team at 901-399-3197. For further questions, please call (901) 344-1435.
Nook toddler beds Recalled for Fall Hazard
The headboard can disconnect from the bed frame and fall onto the bed, posing an entrapment hazard to children.
Consumer should immediately take the recalled toddler bed away from children and contact The Land of Nod for instructions on receiving a full refund. The Land of Nod is contacting all known purchasers directly.
Propane (LP) Gas Recalled for Fire Hazard
The recalled propane may not contain sufficient levels of odorant to help alert consumers to a gas leak. Failure to detect leaking gas can present fire, explosion and thermal burn hazards.
Consumers should not attempt to test the propane themselves. Instead, consumers who have propane delivered to storage tanks should immediately contact their supplier or Western Gas to determine whether their propane is affected and arrange for a free inspection. If the inspection confirms the propane contains insufficient levels of odorant, Western Gas will promptly arrange for additional odorization or replacement of the under-odorized propane. Consumers who have purchased a portable cylinder should contact the retailer or the Western Gas hotline to determine whether their propane may be affected and if so, return the cylinder to the retailer for a replacement. If consumers do smell even a faint odor of gas or a gas leak, they should immediately leave the building and call 911 or their gas supplier from a neighbor’s phone. Do not light a match, turn on a light or switch on anything electrical.
Inflator Component may Detach/FMVSS 214, 226
If the component detaches during deployment, it may enter the passenger compartment and be a projectile within the vehicle cabin, increasing the risk of injury.
Nissan will notify owners, and dealers will replace the side curtain air bags, free of charge. The recall began February 13, 2018. Owners may contact Nissan customer service at 1-800-647-7261.