2015 Product Recalls
7,426 recalls issued in 2015.
Showing 21–40 of 7,426 recalls
Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immedi
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Nobel Biocare sent an Important - Field Correction letter dated March 6, 2015, to all affected customers and another recall letter dated dated March 10, 2015, to all affected customers to inform them that Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. The firm's internal analysis has confirmed that this material is not according to their standards. The letters provide the problems identified and the actions to be taken. Customers were instructed to return the affected product(s) not yet used to Nobel Biocare to receive a replacement product. Customers were also instructed to complete the attached Acknowledgement form and fax it to 714-282-5073 or email it to aeinfo@nobelbiocare.com. Customers with questions were instructed to contact their customer service department. For questions regarding this recall call 714-282-4800.
Fat Bastard Gourmet Chick Dip Honey Roasted Hickory Smoke Sassy Barbecue, Net Wt. 12 Fl. Oz. (375 ml), UPC 8 91929 12702 8. The responsible firm name on the label is The Family Jewels, Montreal, MO 65591.
Product contains undeclared honey.
Loose Steering Gearbox Bracket
If the bracket fasterner loosens it can cause loss of vehicle control, increasing the risk of a crash.
Temsa will notify owners, and dealers will replace the fastener bolts, free of charge. The recall began on February 4, 2016. Owners may contact Temsa customer service at 1-404-602-0151.
Incorrect Torque of Camber Caster Kit Bolt
An insufficiently torqued bolt may become loose and fall out causing vehicle misalignment. Loss of vehicle control is possible, increasing the risk of a crash.
Micro Bird will notify owners, and dealers correct the torque, free of charge. The recall began on January 18, 2016. Owners may contact Micro Bird customer service at 1-819-477-2012. Micro Bird's number for this recall is 15-065-AUC.
Incorrect Torque of Camber Caster Kit Bolt
An insufficiently torqued bolt may become loose and fall out causing vehicle misalignment. Loss of vehicle control is possible, increasing the risk of a crash.
Micro Bird will notify owners, and dealers will correct the torque, free of charge. The recall began on January 18, 2016. Owners may contact Micro Bird customer service at 1-819-477-2012. Micro Bird's number for this recall is 10-065-AUS.
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advise on action to be taken by the customer: Identify the device with the same catalogue number and lot number Return the device to Pega Medical Inc. to the address shown below using the FedEx account. For further questions please call the firm at 450-688-5144 x. 242.
Martha Stewart Collection™ 10-piece Stainless Steel Coo Recalled for Injury Hazard
The metal discs that cover the frying pan's rivets can pop off and hit consumers, posing an injury hazard.
Consumers should immediately stop using the 8- and 10-inch frying pans from the cookware set. The other items from the cookware set are not affected by this recall. Consumers who purchased the cookware sets from Macy's or macys.com should return the frying pans to Macy's or macys.com for a store credit for the full value of the two frying pans. Consumers who purchased the cookware sets from a Military Exchange should return the frying pans to the Military Exchange for a full refund.
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-
Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes
The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 4/27/2015 to their customers (i.e., end-user level, its direct accounts and hospitals) via overnight on 04/27/2015. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: a. send Recall Instructions and a listing of their accounts who were shipped affected product (also included were labels, Training forms, Record of Destruction Forms) b. notify Distributors and Hospitals with a list of products shipped to their account with instructions to place any remaining inventory in quarantine. c. document the lots/quantities labeled at their accounts and complete and return this information on the "Affected Product Listing" to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com even if your distributor no longer has any inventory. d. conduct training at the hospitals and this training will be documented on the Recall Training form. e. leave Record of Destruction Forms at the hospital for completion/return to DeRoyal as products are discarded/destroyed. If you have questions or need assistance with the recall, please contact me at 865-362-6465 or tmarsee @deroyal.com.
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to im
Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized.
LANX sent an URGENT: Recall letter dated November 5, 2013, to all affected customers via Federal Express, Overnight delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product to the firm. Customers with questions were instructed to contact Field Inventory Management. For questions regarding this recall call 303-501-8402.
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray.
TransAmerican Medical sent an Urgent Medical Device Correction letter dated August 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all potential users in their facility are made aware of the safety notification and the recommended actions. If the customers system does produce an uncommanded X-ray, turn the system off immediately. Remove the Spectre Wireless Footswitch and receiver and reinstall the standard OEM footswitch. Follow proper shutdown/system reboot instructions as indicated in the system operator's manual. Customers will be contacted to make arrangements for replacement of their TMi Spectre Wireless Footswitch at no charge. Customers will be provided a new TMI Spectre Wireless Footswitch and instructions on how to return the affected footswitch. Customers with questions were instructed to call 801-796-7335, ext 203.
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
DeRoyal sent an Urgent: Voluntary Recall letter dated April 17, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Check your inventory for the product and specific lot number from the attached Recall Response Form. 2. If you have affected inventory, please destroy it and dispose of it according to your facilitys procedures. 3. Record all information on the included Recall Response and Notice of Destruction forms. 4. If you purchase through a distributor, please indicate their name/location on the Notice of Destruction Form so that we may issue credit appropriately. 5. Return both forms to recalls@deroyal.com or 865-362-3716 (fax) even if you no longer have affected inventory. 6. Once we have received your Recall Response and Notice of Destruction forms, you will receive credit for destroyed product as indicated on the form. 7. If you are a distributor of these products, please forward this recall notice on to your end-users, or provide us with your customer listing and we will gladly contact them for you. For questions regarding this recall, please contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.
Impaired Dynamic Stability Control (DSC) Functions
Impaired DSC functionality may negatively impact vehicle handling and braking and increase the risk of a crash.
BMW will notify owners, and dealers will inspect the DSC hydraulic unit, and replace if necessary, free of charge. The recall began on February 8, 2016. Owners may contact BMW customer service at 1-800-525-7417.
Low Pressure Fuel Line Connection
A fuel vapor leak during engine start increases the risk of a fire.
Ferrari will replace the low pressure fuel line assembly connection, free of charge. Affected vehicles are located in dealer inventory and will be remedied before customer retail. The recall began on December 18, 2015. Owners may contact FNA customer service at 1-866-551-2828.
Electric Entry Steps may Become Unstable
Unstable entry and exit steps increase the risk of injury.
Dealers will install a retainer bracket on the double step assemblies and the Coachstep Linkage Assembly will be replaced and a retainer bracket will be installed on the trip step assemblies. The recall began on Ferbuary 10, 2016. Owners may contact Tiffin customer service at 1-256-356-8661, or Lippert customer service at 1-574-537-8900.
Vanity Lamp Short may Result in Fire
The vanity lamp wiring may short, increasing the risk of a vehicle fire.
Chrysler will notify owners, and dealer will install clearance for sun visor wiring, protection from sharp edges, and replace the sun visor, free of charge. The recall began on July 28, 2016. Owners may contact Chrysler customer service at 1-800-853-1403. Chrysler's number for this recall is R71.
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Each customer will be required to return a completed confirmation fax-back to Siemens.
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
Sarin Group US distributed a Field Safety Notice dated December 5, 2013 to all affected customers and distributors. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite. Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call 303-467-6527 or 303-467-6503.
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Clinical Innovations sent an "Urgent - Medical Device Recall" letter dated December 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They will be instructed to quarantine remaining product. A company representative will visit the hospital and retrieve the product in accordance to instructions detailed on the Representative Recall Reconciliation Instructions. The representative will reconcile the inventory on the Field Reconciliation Form and return the product to Clinical Innovations as indicated on the instructions. The address for the devices to be returned is included on the Representative Recall Reconciliation Instruct Clinical Innovations is working diligently to resolve this issue. In the meantime ,please quarantine any remaining product in your hospital. A company representative will contact you and make arrangements for the return of the product. Clinical Innovations will provide replacement product as soon as it becomes available. If you have any questions,call Clinical Innovations,at 1-(888)268-6222 or your service representative, as is the name of the Company Contact.
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
BIOTRONIK sent the Important Product Information letter and the Acknowledgement of Important Product Information Form, dated June 20, 2015, to affected physicians with the following recommendations: -Review programming settings for your patients with CRT-P or CRT-D devices. -If you have a patient with a device programmed to Ventricular pacing: LV, arrange to have the patients device reprogrammed to an appropriate approved mode (i.e. "Ventricular pacing: RV" or "Ventricular pacing: BiV"). -Physicians are requested to sign the Acknowledgement of Important Product Information Form and immediately fax to 800-913-6993 or email to UScompliance@biotronik.com. BIOTRONIK'S representative will update your programmer with approved 1502.U programmer software. Following this update, the Ventricular pacing: LV feature will no longer be available. However, a device previously programmed with "Ventricular pacing: LV will remain programmed in this mode unless and until the pacing mode setting is changed. If you have any questions concerning this Important Product Information, please contact the BIOTRONIK Technical Services Department: Telephone: 1-(800) 284-6689 (24-hour service)
Power Steering Hose Clamp Incorrectly Positioned
If the power steering fluid return hose detaches, it would leak fluid and increase the risk of a fire.
Chrysler will notify owners, and dealers will inspect the return power steering hose clamp, repositioning the clamp as necessary, free of charge. The recall began on February 5, 2016. Owners may contact Chrysler customer service at 1-800-853-1403. Chrysler's number for this recall is R68.