U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Urologix is recalling certain lots of targis¿ system coolant bag devices distributed over a two week period. the devices are packaged into disposable procedure kits containing a microwave catheter, a coolant bag and a rtu plus¿ balloon.
the reason for this recall involves three lots of coolant bags that contain an increased risk of leakage of water at the sensor module. this leak is detectabl.
Acción
Urologix, Inc. sent an "IMPORTANT RECALL INFORMATION" letter dated April 28, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs the customers to identify the affected kit lots, remove the Coolant Bag pouch(s) and to complete and return a Return Material Authorization form with the product(s). Additionally, an enclosed Customer Acknowledgement Form should be completed and faxed to 763-475-1443.
Customers with questions should contact the Director of Regulatory and Quality at 763-475-1400.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope and/or accessories - Product Code KOG
Causa
There is a potential for the sterile barrier to be compromised in multiple lots of blake silicone drains, blake silicone drain kits, blake cardio connectors, j-vac reservoirs, j-vac drain adaptors.
Acción
Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall.
Customers with questions regarding this recall are directed to call 1-866-664-1401.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope and/or accessories - Product Code KOG
Causa
There is a potential for the sterile barrier to be compromised in multiple lots of blake silicone drains, blake silicone drain kits, blake cardio connectors, j-vac reservoirs, j-vac drain adaptors.
Acción
Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall.
Customers with questions regarding this recall are directed to call 1-866-664-1401.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope and/or accessories - Product Code KOG
Causa
There is a potential for the sterile barrier to be compromised in multiple lots of blake silicone drains, blake silicone drain kits, blake cardio connectors, j-vac reservoirs, j-vac drain adaptors.
Acción
Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall.
Customers with questions regarding this recall are directed to call 1-866-664-1401.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope and/or accessories - Product Code KOG
Causa
There is a potential for the sterile barrier to be compromised in multiple lots of blake silicone drains, blake silicone drain kits, blake cardio connectors, j-vac reservoirs, j-vac drain adaptors.
Acción
Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall.
Customers with questions regarding this recall are directed to call 1-866-664-1401.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope and/or accessories - Product Code KOG
Causa
There is a potential for the sterile barrier to be compromised in multiple lots of blake silicone drains, blake silicone drain kits, blake cardio connectors, j-vac reservoirs, j-vac drain adaptors.
Acción
Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall.
Customers with questions regarding this recall are directed to call 1-866-664-1401.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, catheter - Product Code DYB
Causa
Molding defect in destination product that render the device unusable.
Acción
Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, catheter - Product Code DYB
Causa
Molding defect in destination product that render the device unusable.
Acción
Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Counter, differential cell - Product Code GKZ
Causa
The recall was initiated because beckman coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the sample aspiration module (sam) during routine use of single-tube presentation station. when the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. the misal.
Acción
Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated May 11, 2011 with an attached Product Correction Response Form to all affected customers. The letter provides the customers with an explanation of the problem identified, potential impact should the problem occur and actions to be taken. The letter states that this issue will be corrected in a future hardware release. Customers were instructed to share this information with laboratory staff and retain this notification as part of Quality System documentation. If ownership or location of the analyzer(s) has been transferred to another laboratory, customers were instructed to provide a copy of the letter to that party. Customers were also asked to complete and return the enclosed Response Form within ten (10) days, so Beckman can be assured they have received this important communication. Questions concerning this notice, were directed to the Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Inhibin-A Immunoassay - Product Code ndr
Causa
The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the manual inhibin a elisa assay has shifted from the assays original calibration.
erroneously elevated results may lead to unnecessary ultrasound testing to confirm
gestational age, patient psychological stress until diagnostic testing is completed, and/or
medical decis.
Acción
Beckman Coulter sent an "Urgent Product Correction" letter dated March 31, 2011 to all affected customers.
The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return.
For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulter
representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Shield, nipple - Product Code HFS
Causa
The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Acción
The firm, Medela, sent an "Important Device Recall" letter dated May 9, 2011 to all of their customers/direct accounts. Medala also began telephoning or visiting the direct accounts/customers on May 18, 2011. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
1) not to use the affected lots and place them in quarantine
2) stop sale and distribution and set aside their existing inventory of the affected product
3) conduct a physical count and record the data on the Product Inventory Form inlcude with this letter
4) complete and return the Product Inventory Form via fax to 800-995-7867 or email jim.hughes@medela.com, even if they have no affected product on hand
5)If you have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. Each affected product will be replaced with (2) non-sterile nipple shields.
5) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots.
Questions about the recall process were directed to Medela Customer Service at 1-888-835-5968 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to notify their customers of the recall, using the enclosed customer letter.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Inhibin-A Immunoassay - Product Code ndr
Causa
The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the manual inhibin a elisa assay has shifted from the assays original calibration.
erroneously elevated results may lead to unnecessary ultrasound testing to confirm
gestational age, patient psychological stress until diagnostic testing is completed, and/or
medical decis.
Acción
Beckman Coulter sent an "Urgent Product Correction" letter dated March 31, 2011 to all affected customers.
The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return.
For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulter
representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Inhibin-A Immunoassay - Product Code ndr
Causa
The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the manual inhibin a elisa assay has shifted from the assays original calibration.
erroneously elevated results may lead to unnecessary ultrasound testing to confirm
gestational age, patient psychological stress until diagnostic testing is completed, and/or
medical decis.
Acción
Beckman Coulter sent an "Urgent Product Correction" letter dated March 31, 2011 to all affected customers.
The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return.
For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulter
representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Inhibin-A Immunoassay - Product Code ndr
Causa
The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the manual inhibin a elisa assay has shifted from the assays original calibration.
erroneously elevated results may lead to unnecessary ultrasound testing to confirm
gestational age, patient psychological stress until diagnostic testing is completed, and/or
medical decis.
Acción
Beckman Coulter sent an "Urgent Product Correction" letter dated March 31, 2011 to all affected customers.
The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return.
For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulter
representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Saw, powered, and accessories - Product Code HAB
Causa
Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
Acción
Smith & Nephew notified customers by an "URGENT - PRODUCT RECALL 1st NOTIFICATION" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to endo.andreturn@smith-nephew.com for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731.