2013 Product Recalls

5,512 recalls issued in 2013.

5,512
Total Recalls
290
CPSC
1,377
FDA Drug
1,026
FDA Device
CPSC 290 FDA Drug 1,377 FDA Device 1,026 NHTSA 708 FDA Food 2,111

Showing 1–20 of 5,512 recalls

NHTSA

Brake Pedal Bracket may Loosen

A loose brake pedal bracket may allow the brake pedal to contact the floor of the cab, which would reduce the vehicle's braking capability and increase the risk of a crash.

Oshkosh will notify owners, and dealers will inspect and correct the brake pedal mounting assembly as necessary, free of charge. The recall began February 7, 2014. Owners may contact Oshkosh at 1-888-686-7278.

NHTSA

Windshield Wiper Motor may Fail

Without functioning windshield wipers, the driver's visibility may be reduced, increasing the risk of a crash.

Prevost will notify owners, and dealers will inspect the vehicles and any affected windshield wiper motor will be replaced, free of charge. The recall began on February 26, 2014. Owners may contact Prevost at 1-418-883-2888. Prevost's number for this recall is SR14-02.

NHTSA

PRNDM Position Indicator/FMVSS 102

The transmission position indicator may not show that the transmission is in first gear (1) and not drive (D). If the drivers pulls into traffic, the vehicle's speed would be limited, resulting in an increased risk of a crash.

GM will notify owners, and dealers will upload the correct transmission software, free of charge. The recall began on January 27, 2014. Owners may contact Chevrolet at 1-800-222-1020 and GMC at 1-800-462-8782. General Motors' number for this recall is 13442.

NHTSA

Interior Side Door Lock May Become Inoperable

If the deadbolt jams, the interior side of the door lock may also jam. A person inside the travel trailer at the time will then be locked in and be unable to exit the vehicle without using the emergency exit, increasing the risk of injury.

Cruiser RV will notify owners, and Fastec will coordinate the inspection and replacement of the cylinders, as needed, free of charge. The recall began January 20, 2014. Owners may contact Cruiser RV at 1-260-562-3500 or Fastec at 1-800-837-2505.

NHTSA

Accessory Bike Rack

Partial blockage of the secondary emergency may hinder egress from the trailer in the event of an emergency, increasing the risk of injury to passengers.

Airstream will notify owners, and will supply two new warning labels, one for the bike rack and one for inside the trailer by the rear secondary exit. This label will also come with installation instructions. The recall began on January 17, 2014. Customers may contact Airstream at 1-937-538-1268.

FDA

GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),

UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.

Beckman Coulter issued an "Urgent: Product Corrective Action" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to: 1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose. 2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample probe is adequately tightened, and proper sample volume and integrity are maintained. A copy of the PCA letter will also be included in all new instrument ship kits. Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .

NHTSA

Interior Side Door Lock May Become Inoperable

If the deadbolt jams, the interior side of the door lock may also jam. A person inside the cargo trailer at the time will then be locked in and be unable to exit the vehicle, increasing the risk of injury.

Sharp Manufacturing will notify owners, and Fastec will coordinate the inspection and replacement of the cylinders, as needed, free of charge. The recall began on February 3, 2014. Owners may contact Sharp Manufacturing at 1-785-363-7336 or Fastec at 1-800-837-2505.

NHTSA

Interior Side Door Lock May Become Inoperable

If the deadbolt jams, the interior side of the door lock may also jam. A person inside the travel trailer at the time will then be locked in and be unable to exit the vehicle, increasing the risk of injury.

Bay Bridge will notify owners, and Fastec will coordinate the inspection and replacement of the cylinders, as needed, free of charge. The recall began in March 2014. Owners may contact Bay Bridge at 1-578-848-7477 or Fastec at 1-800-837-2505.

NHTSA

Interior Side Door Lock May Become Inoperable

If the deadbolt jams, the interior side of the door lock may also jam. A person inside the travel trailer at the time will then be locked in and be unable to exit the vehicle without using the emergency exit, increasing the risk of injury.

Riverside will notify owners, and Fastec will coordinate the inspection and replacement of the cylinders, as needed, free of charge. The recall began on January 16, 2014. Owners may contact Riverside at 1-765-472-3920 or Fastec at 1-800-837-2505.

NHTSA

Misaligned Lock Washer and Pin

The misalignment could prevent the pin from engaging. Additionally, the jam nut would not be torqued to specification, creating the potential for wheel separation, which could increase the risk of a crash.

Meritor will notify Trac Intermodal, and Meritor service personnel will inspect and repair the axles, as necessary, free of charge. The recall is expected to begin on January 20, 2014. Owners may contact Meritor at 1-800-535-5560. Meritor's number for this recall is C14AB.

FDA

Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.

Stryker sent a Urgent Medical Device Recall notice dated June 18, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to " Return the enclosed post card to confirm receipt of this notification. " Locate the chairs listed in this notice. " Call 269-389-6750 to arrange shipment of the chairs to Stryker Medical. " If you have loaned or sold any of the chairs listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location. " If you have disposed of any of the affected chairs and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. We apologize for any disruption that this advisory notice may cause. We strive to make products that meet our customer expectations for quality and durability. For further questions please call (269) 389-6927

CPSC

Cabrinha H2 Hydra Series Binding Recalled for Poisoning Hazard

The binding can detach from its base while riding and lead to loss of control, which poses a risk of injury.

Consumers should immediately stop using the recalled binding and contact any Cabrinha authorized dealer for a free replacement binding. A list of authorized dealers can be found at www.cabrinhakites.com/dealers.html

CPSC

2012 Source Eleven and Source Expert Disc bicycles with Recalled for Fall Hazard

The set screws in the front hub of the recalled bicycles can loosen and stop the front wheel from turning, posing a fall hazard to consumers.

Customers should immediately stop riding the recalled bicycles and bring them to an authorized Specialized dealer for a free replacement front wheel and new Supernova front hub. For a list of authorized dealers go to www.specialized.com/ and click on Dealers in the upper right hand corner of the page.

CPSC

Zoom Car Seat Adapter Recalled for Fall Hazard

Adapter clips can loosen on the stroller frame, posing a fall hazard.

Consumers should stop using these adapters and contact Joovy for a free repair kit to help assure proper attachment to Zoom stroller frames.

FDA

DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.

A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.

DePuy Spine issued an Urgent - Voluntary Product Recall Notification dated July 24, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue the use of the affected product and to remove the EXPEDIUM Offset Torque Wrenches from service and return to DePuy Synthes Spine until direction can be provided by DePuy Synthes Spine regarding a replacement torque limiting device. For questions regarding this recall call 508-828-3769.

FDA

ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.

The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.

DePuy Synthes sent a Urgent Information Medical Device Correction Notice to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed upon visual inspection, if the reamer extension is found to have one or more tabs broken, please do not use the reamer extension. The reamer extension will still engage with one tab intact and no clinical implications have been identified with the use of the reamer extension with one tab, but DePuy recommends it be returned and the alternate reamer extension device be used. If both tabs are broken, the reamer extension will not engage and DePuy recommends it be returned and the alternate reamer extension device be used. A reamer extractor is available in the instrument kit for removal of the reamer if necessary. In order to reduce the risk of breaking the tabs during surgery, the Reamer Extension should only be used to drive the Distal Reamer axially within the patients femoral canal. The instrument is NOT intended to be used for side-cutting or lateralizing the femoral canal, therefore, no off-axis force should be applied during distal reaming. The purpose of this communication is to inform you of this device correction and request acknowledgement of receipt of this letter by signing and returning the Surgeon Response Card within 14 days of receiving this notice. Response cards should be faxed to Fax Number: 574-371-4939. For product-related questions, please contact your local DePuy Orthopaedics Sales Representative. For clinical-related questions from surgeons, please have them contact DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am to 5 pm EST.) For questions about device correction information provided, 574-372-7333 (M-F: 8 am to 5 pm EST.)

NHTSA

Wrong Tire And Loading Information Label/FMVSS 110

If the vehicle is loaded to the capacity stated on the incorrect label, and the tire load capacity is exceeded, the vehicle may experience structural damage to the tire. If this occurs, this may lead to tire failure which could increase the risk of a crash.

Nissan will notify owners and will provide owners with a correct label to install, free of charge. The recall is expected to begin on January 21, 2014. Owners may contact Nissan at 1-800-647-7261.

NHTSA

Interior Side Door Lock May Become Inoperable

If the deadbolt jams, the interior side of the door lock may also jam. A person inside the trailer at the time will then be locked in and be unable to exit the vehicle, increasing the risk of injury.

Cargo South will notify owners, and Fastec will coordinate the inspection and replacement of the cylinders, as needed, free of charge. The recall is expected to begin by early February 2014. Owners may contact Cargo South at 1-229-468-5659 or Fastec at 1-800-837-2505.

FDA

T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.

One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.

Medtronic sent an Urgent Voluntary Market Removal Recall letter dated August 9, 2013 with Recall Questionnaires and Confirmation forms included to Risk Managers and Sales Representatives. The letter identified the affected product, problem and action to be taken. Customers were instructed to remove the affected product, discontinue use and contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product. For questions call your Medtronic Sales Representative or Global Quality Department at 800-876-3133.

FDA

Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum, plasma and urine. Dimension(R) CA Flex(R) reagent is used on the Dimension(R) clinical chemistry system as an in vitro diagnostic test intended for the quantitative determination of calcium activity in human serum, plasma and urine.

Siemens Healthcare Diagnostic has confirmed a high frequency of "Abnormal assay" flags and imprecision. Test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dL at a concentration of 9.26 mg/dL.

An Urgent Field Safety Notice datey July 2011 was issued to all affected customers. Customers are being advised to immediately discontinue use and discard any remaining inventory of Dimension(R) CA Flex(R0 reagent cartridge - lot EA2153. Replacement order for the affected lot is in process, and will be sent to impacted customers free of charge. Customers were instructed to forward the Field Safety Notice to anyone whom they may have distributed the affected product. For questions regarding this recall call 302-631-6299.