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
Bronchoscope accessory - Product Code KTI
Causa
Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
Acción
Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
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
Bronchoscope accessory - Product Code KTI
Causa
Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
Acción
Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
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
Bronchoscope accessory - Product Code KTI
Causa
Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
Acción
Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
The anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
Acción
The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887.
For questions regarding this recall call 561-494-3706.
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
The anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
Acción
The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887.
For questions regarding this recall call 561-494-3706.
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
The anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
Acción
The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887.
For questions regarding this recall call 561-494-3706.
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.
Envoy medical is conducting a voluntary correction of a limited number of esteem programmers, part of the esteem totally implantable hearing system, to reduce their susceptibility to noise interference.
Acción
Envoy Medical Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-233-1204 for questions relating to this notice.
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
Bronchoscope (flexible or rigid) - Product Code EOQ
Causa
Conmed received complaints from a user facility reporting that the wang transbronchial aspiration needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. if the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Acción
ConMed Corporation sent an Urgent Field Safety Notice letter dated November 30, 2012 with Response Form , to all affected customers via USPS Priority Mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete Attachment II and return it with any unused affected product to:
ConMed Corporation
525 French Road, Utica, NY 13502
United Sates of America
For information regarding this recall call 315-624-3225.
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
Bronchoscope (flexible or rigid) - Product Code EOQ
Causa
Conmed received complaints from a user facility reporting that the wang transbronchial aspiration needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. if the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Acción
ConMed Corporation sent an Urgent Field Safety Notice letter dated November 30, 2012 with Response Form , to all affected customers via USPS Priority Mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete Attachment II and return it with any unused affected product to:
ConMed Corporation
525 French Road, Utica, NY 13502
United Sates of America
For information regarding this recall call 315-624-3225.
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
Bronchoscope (flexible or rigid) - Product Code EOQ
Causa
Conmed received complaints from a user facility reporting that the wang transbronchial aspiration needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. if the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Acción
ConMed Corporation sent an Urgent Field Safety Notice letter dated November 30, 2012 with Response Form , to all affected customers via USPS Priority Mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete Attachment II and return it with any unused affected product to:
ConMed Corporation
525 French Road, Utica, NY 13502
United Sates of America
For information regarding this recall call 315-624-3225.
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
Bronchoscope (flexible or rigid) - Product Code EOQ
Causa
Conmed received complaints from a user facility reporting that the wang transbronchial aspiration needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. if the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Acción
ConMed Corporation sent an Urgent Field Safety Notice letter dated November 30, 2012 with Response Form , to all affected customers via USPS Priority Mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete Attachment II and return it with any unused affected product to:
ConMed Corporation
525 French Road, Utica, NY 13502
United Sates of America
For information regarding this recall call 315-624-3225.
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
Prosthesis, laryngeal (taub) - Product Code EWL
Causa
Helix medical llc is recalling the blom-singer indwelling tep occluder due to an invalid expiration date.
Acción
A recall letter dated March 8, 2012, was sent to customers who purchased the Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO). The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to contact Customer Service Center at (800) 477-5969 if they have products to be returned. Customers were instructed to return Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO) to:
Helix Medical, LLC
Attn to: Customer Service-IN2004-TO.
1110 Mark Avenue
Carpinteria, CA 93013
For questions regarding this recall call 805-684-3304.
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.
On 9/1/2010 bomimed, inc. winnipeg, mb, canada initiated a recall of their bomimed integrated reusable laryngoscope blades (macintosh & miller styles - all sizes), model #ol-32d0 to ol-32d4 & ol-32e00, ol-32e0, ol-32e1, ol-32e2, ol-32e3, ol-32e4.
Acción
BOMImed sent a "Medical Device Safety Alert & Correction Action" letter by Fax and Mail on 11/25/2010 to the consignee. The product issue was described and recommended actions to mitigate risk were provided. Contact number is 1-800-667-6276 ext. 234.
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
Hearing aid, bone conduction - Product Code LXB
Causa
Sonitas received reports of stress cracking on the soundbite microphone tube.
Acción
Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
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
Hearing aid, bone conduction - Product Code LXB
Causa
Sonitas received reports of stress cracking on the soundbite microphone tube.
Acción
Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
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
Hearing aid, bone conduction - Product Code LXB
Causa
Sonitas received reports of stress cracking on the soundbite microphone tube.
Acción
Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
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
Hearing aid, bone conduction - Product Code LXB
Causa
Sonitas received reports of stress cracking on the soundbite microphone tube.
Acción
Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
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
Hearing aid, bone conduction - Product Code LXB
Causa
Sonitas received reports of stress cracking on the soundbite microphone tube.
Acción
Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
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
Bronchoscope accessory - Product Code KTI
Causa
Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
Acción
Acclarent sent an "Urgent Voluntary Product Recall" letter dated January 31, 2012 by US mail, return receipt requested to all affected customers. Additionally, customers known to have scheduled procedures using the affected product were notified by phone to advise them of the recall. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use and return any remaining in stock per the instructions provided. The letter provides additional information and photographs illustrating how to identify the recalled product. Customers were advised to complete the enclosed Business Reply Card regardless of whether they have or do not have product subject to this recall in their possession and mail to Stericycle. Customers were instructed to distribute this information to all staff within their department who uses the affected product. For further questions call 1-866-781-1173 or contact your Acclarent Sales 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
Stimulator, caloric-water - Product Code ETP
Causa
Leica microsystems received complaints stating that the zoom function of the leica m822 surgical microscope locked up during use.
Acción
The firm, Leica Microsystems, Inc., sent a "Medical Device Correction" notice dated December 21, 2011 to all affected customers by e-mail. The product, problem, and actions to be taken by the customers were addressed. Customers were instructed- DO NOT USE use the affected product until the software could be upgraded and complete and return the Acknowledgement Form via fax to: 1-847-607-3147 or Scan and send to elizabeth.culotta@leica-microsystems.com. Leica Microsystems representatives will contact the customers to make necessary arrangements to complete the software upgrade.
If you have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.
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
Nasopharyngoscope (flexible or rigid) - Product Code EOB
Causa
Vision-sciences is recalling the vision-sciences battery charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
Acción
Vision Sciences sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected product from inventory. A Tracking/Verification Form was provided for customers to complete and return to the firm. Contact the firm at 800-874-9975 for questions regarding this recall.
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
Nasopharyngoscope (flexible or rigid) - Product Code EOB
Causa
Vision-sciences is recalling the vision-sciences battery charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
Acción
Vision Sciences sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected product from inventory. A Tracking/Verification Form was provided for customers to complete and return to the firm. Contact the firm at 800-874-9975 for questions regarding this recall.
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
Screw, oral - Product Code KBW
Causa
Biomet microfixation, jacksonville, fl is recalling part number 01-6577, 2.0x7 mm fossa x-drive screws, 5 pack, lot # 233270. this product is being recalled due to the possibility that the pack may have contained another part, 01-6581 2.0x11 mm fossa x-drive screws, 5 pack.
Acción
Biomet Microfixation, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
The letter instructs customers to complete and return an Inventory Reconciliation form via fax to 904-741-9425. The form requests that customers indicate whether they want to keep the product or return for credit.
Customers can contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400 ext. 468 for questions regarding this recall.
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
Cochlear implant - Product Code MCM
Causa
Cochlear implant device component was mis-labeled.
Acción
On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier. The letter described the mislabeling issue and actions for consignees.
Customers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic). Direct questions about the recall by calling at 1-800-523-5798.
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
Implant, Cochlear - Product Code MCM
Causa
All unimplanted clarion and hiresolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
Acción
Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.