2012 Product Recalls
5,173 recalls issued in 2012.
Showing 5101–5120 of 5,173 recalls
2012 Model Year Giant Defy Advanced and Avail Advanced Recalled for Fall Hazard
The fork can crack, posing a fall hazard to riders.
Consumers should immediately stop riding the recalled bicycles and contact any authorized Giant Bicycle dealer for a free inspection and replacement of the fork.
Amia desk chairs Recalled for Fall Hazard
The pivot pins installed in the control mechanism under the chair seat can fall out, posing a fall hazard to the user.
Consumers should immediately stop using the chairs and contact Steelcase to receive adhesive covers to apply over the pivot pins on their chairs. These pin adhesive covers can be applied without the use of a tool in less than five minutes. The firm is contacting all known purchasers.
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm. For further Information, contact Covidien at 1-800-635-5267.
ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagn
The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics' customers received ProScreen 5-panel cups that contain First Check THC cups. The recalled products are mislabeled. If the USD customer receives the FirstCheck tes, there will be no instructions for use
The recall communication was initiated on June 9, 2011 with Ameditech Inc. forwarding an Urgent Medical Device Recall notification with an attached Verification Form (via phone and written notification) to the affected distributor. The letter provides the distributor with an explanation of the problem identified and actions to be taken. The distributor was required to: cease distribution of the affected lot and provide remaining inventory count to Ameditech; destroy any remaining inventory of these lots and document destruction per site requirements; and ensure that all user of the device have received a copy of the Urgent Medical Device Recall. In addition, the distributor was instructed to complete and return the enclosed Verification Form with in 10 days. For any questions about the information contained in this notice, contact Ameditech at amd.complaint@alere.com or call 858-535-1968.
HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9, Gunjang-ri, Ganam-myeon, Yeoju-gun, Kyungki-do, Korea
Marketed without 510(k)
Marknew Products, LLC, sent an Important Recall Notice to their customers on November 27, 2007, advising them that all Haeng Lim Seo Won Acupuncture Needles that they have received, have not been cleared for distribution in the USA. All customers have been requested to return product back to Marknew Products for credit. A response form was included. If customers have questions concerning this product, they are asked to call 562-908-5000.
Edwards Lifesciences Aquarius System Model GEF09800.
There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the Aquarius will trigger an alarm, however, users are able to override this alarm and continue therapy. It is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this may result in serious injuries or death.
Edwards is continuing a field corrective action related to the possibility of fluid imbalance when using the Aquarius. In order to mitigate some of the risk associated with this problem, Edwards sent notifications to consignees advising of mitigation steps. Consignees were provided: a description of the affected product, problem, and potential hazard; advice on action to be taken; and revised device labeling. Additionally, consignees were notified of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. Although Edwards does not believe there is a need to stop using the Aquarius system at this time, clinicians should weigh the risks/benefits to the patients before continuing the use of the device Edwards first provided some of this information to consignees in a Field Safety Notice on March 16, 2009. On January 11, 2010, Edwards provided an Urgent Product Recall letter to consignees which updated and expanded the earlier communication. The FDA classified this as a Class I recall.
MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
AIR BAG CLOCK SPRING ASSEMBLY
IF THE CLOCK SPRING DEVELOPS HIGH RESISTANCE, IN THE EVENT OF A CRASH, THE DRIVERS AIR BAG WILL NOT DEPLOY AND WILL NOT BE ABLE TO PROPERLY PROTECT THE DRIVER, INCREASING THE RISK OF INJURIES.
KIA WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE VEHICLE'S AIR BAG CLOCK SPRING CONTACT ASSEMBLY, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JULY 11, 2012. OWNERS MAY CONTACT KIA CUSTOMER ASSISTANCE CENTER AT 1-800-333-4542.
Royal Prestige 9-Ply Thermal Wall Cookware Recalled for Fire Hazard
The cookware can collapse, crimp or severely deform when exposed to heat, posing a burn and fire hazard to the consumer and nearby property.
Consumers should stop using the cookware immediately and contact Hy Cite for instructions for the return of recalled pans and for receiving a free replacement pan with a supplemental credit voucher for additional products.
New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: EtchMaster***Cordless Handpiece***Pats. Pend. Groman, Inc. Adapater P/N 747 WWW.DisposableAirAbrasion.com 1-800-906-9298. The Cordless Etcher air brush is powered by CO2 mini-cartridges to deliver pressurized gas to the EtchMaster pre-filled disposable micro air abrasive tips. T
Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges.
Groman Inc. sent a "HAZARD NOTICE: IMPORTANT NOTICE ABOUT CORDLESS ETCHER HAZARD DUE TO IMPROPER USE" letter dated March 1, 2011 to all affected customers. The letter describes the product, problem, and advises the customers of the proper use of the device. Customers with questions and concerns, should contact the President of Groman Dental at 800-906-9298 ext. 709.
BRAKE CALIPER PIN
THE BRAKE CALIPER PINS COULD BACK OUT RESULTING IN LOSS OF BRAKE FUNCTION, INCREASING THE RISK OF A CRASH.
TRACKER WILL NOTIFY OWNERS, AND DEALERS WILL INSPECT THE CALIPER, AND REPAIR THE TRAILERS AS NECESSARY, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 30, 2012. OWNERS MAY CONTACT TRACKER MARINE AT 1-417-873-4588.
INCORRECT WHEEL CAP CENTER/LOOSE WHEELS
WHEEL SEPARATION CAN LEAD TO LOSS OF CONTROL OF THE TRAILER INCREASING THE RISK OF A CRASH. A DETACHED WHEEL ALSO POSES A RISK OF INJURY TO PEDESTRIANS AND OTHER VEHICLES.
THOR WILL NOTIFY OWNERS, AND DEALERS WILL INSPECT THE WHEELS, AND REPAIR THE TRAILERS AS NECESSARY, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 25, 2012. OWNERS MAY CONTACT THOR INDUSTRIES, INC. AT 1-937-596-6849.
EVAPORATORS
IF SUFFICIENT ARCING OCCURS, THE FUSE HOLDER MAY MELT, AND A VEHICLE FIRE MAY OCCUR.
GLAVAL 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 14, 2012. (SEE CARRIER'S RECALL CAMPAIGN 11E-003.) OWNERS MAY CONTACT CARRIER AT 1-800-348-7440.
AMO PhacoFlex Il Model SI40NB Intraocular Lenses
These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
On October 31, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses. AMO will provide updates to the FDA, including all information regarding the recall effectiveness and test results obtained as part of our continuing investigation, as part of the recall progress reports.
ACT diff 2 Analyzer (Automated differential cell counter)
Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.
A letter issued to users informing them of the incompatability of the Coulter ACT diff 2 Analyzer with the use of Monoject blood collection tubes made by Tyco Healthcare Group/Kendall Healthcare. Customers choosing to use these tubes are instructed to uncap the tubes and analyze the samples,as open vial samples.
Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors a
CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL).
Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to one affected customer in Massachusetts. The letter described the product, problem, and actions to be taken by the customers. Customers were instructed to review previous diagnoses made from this electrocardiograph to mitigate any inappropriate recordings or treatment made, and dispose of the mislabeled ECG cable to prevent its use. Spacelabs replaced the affected ECG cable with the new ECG cable. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneo
Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system.
Baxter sent service technicians to the consignees location on July 14, 2010 and October 6, 2010 and conducted the ground impedance and leakage current test on the affected pumps. The pumps were found with specifications.
BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1
An Urgent Medical Device Removal Notice was issued by BIOMET on May 2, 2008, to all customers in the United States via overnight carrier (UPS). The U.S. Removal Notice was used as a template for all global communications regarding this urgent removal notice. Included in this recall correspondence were three Recall Letters; one for direct customers, one for Physicians and one for distributors. The notice informed customers of the problem and the risks associated with the use of this product (note: The Physician letter included more detail instruction for physician with patients already implanted with the devices). The customers were instructed to take the following actions: (1) Immediately locate, discontinue use , and quarantine the implants referenced. (2) Return the product listed in table below to Biomet Sports Medicine at the address provided. (3) Include a copy of this letter with your returned products. (4) Use priority carrier for your shipment. (5) If you have further distributed this product, you MUST notify hospital personnel of this action, via the enclosed Dear Biomet Customer notice. For questions related to this notice, an 800 number and contact person was referenced in the letter. The recalled product will be returned to the firm's warehouse and quarantined until final disposition is determined after notification to the local FDA office.
MALFUNCTIONING SIDE MARKER/DIRECTIONAL LIGHTS
FAILURE OF THE SIDE MARKER/DIRECTIONAL LIGHTS TO ILLUMINATE WILL RESULT IN DECREASED VISIBILITY OF THE VEHICLE AND/OR MISINFORM OTHER DRIVERS AS TO THE INTENDED DIRECTION OF TRAVEL, EITHER OF WHICH COULD INCREASE THE RISK OF A CRASH.
DTNA WILL NOTIFY OWNERS, AND THE BULK-HEAD MODULE SOFTWARE WILL BE UPDATED BY DTNA AUTHORIZED SERVICE FACILITIES, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 2, 2012. OWNERS MAY CONTACT DTNA AT 1-800-547-0712.
AXLES/STEERING ARM BOLTS/MERITOR
LOSS OF STEERING CONTROL MAY INCREASE THE RISK OF A CRASH.
FORD WILL NOTIFY OWNERS, AND DEALERS WILL INSPECT THE STEERING ARM AND STEERING KNUCKLE, AND REPAIR THE VEHICLES AS NECESSARY, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 20, 2012. OWNERS MAY CONTACT FORD MOTOR COMPANY CUSTOMER RELATIONSHIP CENTER AT 1-866-436-7332.