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.
Extra notes in the data
Staple, implantable - Product Code GDW
Reason
Cardica, inc. has received reports that use of the blue cartridges with the microcutter
xchange 30 stapler was associated with incomplete firing of staples, potentially resulting in an
incomplete transection or anastomosis of tissue during the surgical procedure.
Action
An Urgent: Medical Device Removal letter, dated November 17, 2015, was sent via Fed Ex. The letter identified the affected device, described the reason for the recall, and provided the instructions to be followed. Customers were asked to check their inventory, and remove and quarantine any affected product. The notice should be forwarded to relevant personnel, and the affected product should be returned along with the completed Reply Form. A credit will be issued for any returned product. A sales representative can be contacted with questions.
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.
Extra notes in the data
Saw, powered, and accessories - Product Code HAB
Reason
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
Action
Zimmer sent an Urgent Medical Device Correction letter dated November 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1. Review this notification.
2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities.
3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified.
4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday.
Zimmer instructed their direct customers that they will upgrade the device with the new electronic during their annual preventative maintenance activities. Until the new upgrade is installed, the firm instructed their customers to follow the Instructions for Use.
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.
Extra notes in the data
Staple, implantable - Product Code GDW
Reason
Cardica, inc. has received reports that use of the blue cartridges with the microcutter
xchange 30 stapler was associated with incomplete firing of staples, potentially resulting in an
incomplete transection or anastomosis of tissue during the surgical procedure.
Action
An Urgent: Medical Device Removal letter, dated November 17, 2015, was sent via Fed Ex. The letter identified the affected device, described the reason for the recall, and provided the instructions to be followed. Customers were asked to check their inventory, and remove and quarantine any affected product. The notice should be forwarded to relevant personnel, and the affected product should be returned along with the completed Reply Form. A credit will be issued for any returned product. A sales representative can be contacted with questions.
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.
Extra notes in the data
Transducer, pressure, catheter tip - Product Code DXO
Reason
Edward lifesciences is recalling intravascular (iv)
administration sets due to the requirement of an additional fda submission to support commercialization (clearance) of the devices.
Action
An urgent product notification letter dated 11/13/15 was to customers to inform them that during an internal documentation review, the requirement of an additional FDA submission to support commercialization (clearance) of the devices was discovered. Customers are informed that the Edwards Lifesciences Intravascular (IV) Administration sets are temporarily unavailable for sale. Customers are informed that there is no increased risk to the patients' health or safety by using products in their current inventory and there is no impact to the IV sets included in pressure monitoring kits (with TruWave pressure transducer or VAMP system). Customers are informed that if they are in need of a substitute IV set, then to call customer service at (800) 424-3278. Customers instructed to respond to the customer response form by faxing it to (800) 422-9329.
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.
Extra notes in the data
Prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained - Product Code LZJ
Reason
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. the component did not pass a half-cycle sterilization.
Action
The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003.
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.
Extra notes in the data
Arthroscope - Product Code HRX
Reason
Product is incorrectly labeled. the blade configuration in the affected lots does not match the description on the label.
Action
On November 20, 2015, customers were notified of the recall via letter. They were asked to take the following actions: Customer immediate actions:
1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located within your facility;
2. Review, complete, sign and return the attached business reply form to Elizabeth Messana (emessan1@its.jnj.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification; 3. Forward this notice to anyone in your facility that needs to be informed;
4. If any potentially affected product has been forwarded to another facility, contact Elizabeth Messana at 508-828-3150; 5. Keep a copy of 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.
Extra notes in the data
Arthroscope - Product Code HRX
Reason
Product is incorrectly labeled. the blade configuration in the affected lots does not match the description on the label.
Action
On November 20, 2015, customers were notified of the recall via letter. They were asked to take the following actions: Customer immediate actions:
1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located within your facility;
2. Review, complete, sign and return the attached business reply form to Elizabeth Messana (emessan1@its.jnj.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification; 3. Forward this notice to anyone in your facility that needs to be informed;
4. If any potentially affected product has been forwarded to another facility, contact Elizabeth Messana at 508-828-3150; 5. Keep a copy of 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.
Extra notes in the data
Arthroscope - Product Code HRX
Reason
Product is incorrectly labeled. the blade configuration in the affected lots does not match the description on the label.
Action
On November 20, 2015, customers were notified of the recall via letter. They were asked to take the following actions: Customer immediate actions:
1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located within your facility;
2. Review, complete, sign and return the attached business reply form to Elizabeth Messana (emessan1@its.jnj.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification; 3. Forward this notice to anyone in your facility that needs to be informed;
4. If any potentially affected product has been forwarded to another facility, contact Elizabeth Messana at 508-828-3150; 5. Keep a copy of 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.
Extra notes in the data
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Reason
Certain model 106 pulse generators demonstrate delays in sensing during use of the 'verify heartbeat detection' feature and exhibit the potential for decreased battery longevity.
Action
Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804
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.
Some tubes were manufactured with the stopper not fully inserted into the tube. this may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
Action
BD sent an "Urgent Product Recall notifications/Recall Response Forms dated November 17, 2015 via email and/or UPS Next Day Mail on November 17, 2015 to their customers. The notification identifies the affected product and problem and actions to be taken. Customers are requested to take the following actions (1) Immediately review their inventory and quarantine the product subject to the recall and immediately discontinue the shipment of the affected product (2) complete the enclosed Recall Response Firm and fax it bat to BD at 1.866.873.0312 or emai to bd8554@stericycle.com (3) Return all affected products with the completed Recall Response Form following the instruction on the enclosed packing instruction and (5) if distributed, identify your customers and notify them immediately of this product recall. If the customers had any questions, they were instructed to contact BD at 1.888.628.0732 between 8 AM and 5 PM Monday through Friday.
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.
Extra notes in the data
Introducer, catheter - Product Code DYB
Reason
Boston scientific is voluntarily recalling its chariot" guiding sheath. to date, boston scientific has received fourteen complaints for shaft separation, four for distal shaft separation.
the most severe outcome of this failure is embolism of device fragments.
Action
Consignees were sent a Boston Scientific "Urgent Medical Device Recall Removal" letter dated November 19, 2015. The letter was addressed to Materials Manager /Field Action Contact. The letter described the problem and the product involved in the recall. Advised consignees to segregate and return affected product to Boston Scientific. Requested consignees to complete and return the "Recall Removal Reply Verification Tracking Form" to MapleGroveFieldActionCenter@bsci.com or fax to 1-866-213-1806.
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.
Extra notes in the data
Screw, fixation, bone - Product Code HWC
Reason
One batch of osteosynthesis screws were manufactured with the incorrect torx imprint on the screw head.
Action
IN2Bones - USA sent an Field Safety Corrective Action Medical Device Batch Recall letter dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Recommended actions :
We therefore you to follow the instructions here below:
1. Identify all I.B.screws with the batches subject of this recall that might still be in your inventory and quarantine them
2. Inform and distribute this Recall Notification to all relevant persons within your organization
3. To distributors only : Identify all I.B.screws with the batches subject of this recall that were delivered to your customers, and if relevant instruct them to also follow these instructions (identification and quarantine)
4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to, comply with the recommendations listed.This fax back form will enable ln2Bones to conduct effectiveness checks.
For any question,plea1se contact our Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +33 7 6188 44 30 or by email:qualite@in2bones.com.
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.
Extra notes in the data
Plethysmograph, impedance - Product Code DSB
Reason
Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).
Action
CNSystems sent an Urgent Medical Device Recall Safety Notice dated December 1, 2015, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. CNSystems decided to perform a voluntary recall of the affected devices and to return the devices after repair (free of charge). For questions regarding this recall call 314-324-2470.
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.
Extra notes in the data
Retractor - Product Code GAD
Reason
Aag received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an fc424r blade. investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier.
Action
The firm, Aesculap, sent an "URGENT MEDICAL DEVICE CORRECTION OR REMOVAL" letter dated 11/17/2015 to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to review the product recall notification in its entirety; do not destroy any affected product; if you have no inventory remaining, notate that on the Product Removal Acknowledgement Form; contact our customer service department for an RGR at 866-229-3002 or email: SetWorld_Orders.BBMUS_Service@aesculap.com and immediately return affected product; complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance department by fax to 610-791-6882 or email to val.strawn@Aesculap.com within two(2) weeks of receipt, even if the total inventory in your possession is zero (0)
Sales Representative will make an appointment to come and exchange the effected product with an interium solution (FC360-Atrium Lift Retractor Set) that will allow any scheduled or unexpected cases, which would require the use of this product. The newly manufactured product will ship automatically when it's available.Then a visit will be scheduled to retrieve the loaner FC360R sets.
If you have any questions, contact Quality Specialist at 610-984-9414 or email to val.strawn@aesculap.com or Product Manager at 610-984-9150 or email to mark.eppedio@aesculap.com.
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.
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Action
Zimmer Biomet initiated a voluntary recall of the Persona¿ EM Proximal Tube and Persona¿ EM Distal Rod due to complaints that the ratchet teeth of the tube are not latching onto the rod via certified mail on 11/24/2015. The firm requests customers quarantine recalled devices, return the customer response forms, and assist in returning the devices to the Zimmer Biomet sales reps. Customers with questions may contact 1-800-348-2759 between 8:00 am and 8:00 pm EST.
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.
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Action
Zimmer Biomet initiated a voluntary recall of the Persona¿ EM Proximal Tube and Persona¿ EM Distal Rod due to complaints that the ratchet teeth of the tube are not latching onto the rod via certified mail on 11/24/2015. The firm requests customers quarantine recalled devices, return the customer response forms, and assist in returning the devices to the Zimmer Biomet sales reps. Customers with questions may contact 1-800-348-2759 between 8:00 am and 8:00 pm EST.
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.
Extra notes in the data
Bottle, collection, vacuum - Product Code KDQ
Reason
Stryker sustainability solutions is recalling the fuhrman pleural & pneumopericardial drainage set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.
Action
The firm, Stryker Sustainability Solutions, sent a "URGENT MEDICAL DEVICE RECALL" letter dated 11/17/2015 to its customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to discontinue the use of the product, and complete the Recall Effectiveness Check Form even if no product has been found in inventory. Customers should return the completed Recall Effectiveness Check Form to their local Stryker Sustainability Sales Representative, email to ssspfa@stryker.com, or mail to: Stryker Sustainability Solutions, 1810 West Drake Drive,Tempe, AZ 85283.
If the firm indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned.
Adverse reactions or quality problems experienced with the use of this product
may be reported to:
- Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555
- http://www.stryker.com/productexperience/
- The FDAs MedWatch Adverse Event Reporting program either online, by
regular mail, or by fax.
If you have any questions, contact Senior Regulatory Affairs Specialist at (888) 888-3433x5506 or email: chelsea.cullen@stryker.com.
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.
Cook medical initiated a voluntary recall of specific lot numbers of the ventriclear ii ventricular drainage catheter set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
Action
Cook Medical issued letter via certified mail on 11/19/2015, for their voluntary recall of the VentriClear¿ II Ventricular Drainage Catheter Set due to being sterilized twice. The Distributor was instructed to forward the recall letter on to its customers, and quarantine any unused recalled devices, and return them to Cook Medical. Customers with questions may contact: Cook Medical Customer Relations 1-800-457-4500 or 1-812-339-2235. Monday
through Friday between 7:30a.m. and 5:00p.m. Eastern Daylight Time or email at
CustomerRelationsNA@cookmedical.com.
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.
Extra notes in the data
Laparoscope, gynecologic (and accessories) - Product Code HET
Reason
A damaged temperature sensor at the endoeye tip caused the distal end to become abnormally hot. excessive heating of the endoeye distal end could result in patient or user injury.
Action
Olympus Corporation of Americas sent a letter dated November 25, 2015, to all affected customers to inspect the serial #'s to identify if the affected lots were in inventory and discontinue of the affected lots. Then return all aftected lots for repair and service. Customers were instructed to contact the Customer Care Center at 800-537-5739, Option 2 for instructions on returninng the ENDOEYE for repair and service. The form should be faxed to 484-896-7128. Customers with questions were instructed to call 484-896-5688.
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.
Reconstructed ecg leads viewed or printed at the information center ix may misrepresent the ecg waveform in specific leads.
Action
Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge.
Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice:
Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG.
The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX.
If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
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.
Extra notes in the data
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Reason
During routine monitoring of complaints, bsc noted that the intellatip mifi xp n4 complaint rate for distal tip bends/kinks was above the anticipated rate in bscs product risk documentation.
Action
Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service. The letter identified the affected products, problem and actions to be taken. Customers were instructed to contact their local Sales Representative to answer any questions.
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.
Reconstructed ecg leads viewed or printed at the information center ix may misrepresent the ecg waveform in specific leads.
Action
Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge.
Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice:
Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG.
The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX.
If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
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.
Reconstructed ecg leads viewed or printed at the information center ix may misrepresent the ecg waveform in specific leads.
Action
Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge.
Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice:
Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG.
The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX.
If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
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.
Extra notes in the data
Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
Reason
The 16 devices distributed in the united states were incorrectly labeled as the monoblock birmingham hip modular head, with labeling not cleared for marketing in the us. the actual devices were monoblock modular femoral head for hemiarthroplasty use.
Action
The firm sent their field safety notices on 11/16/2015 by letter delivered by Fed Ex (overnight) and email. Non- responding consignees will be contacted within 4 weeks of the initial 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.
Extra notes in the data
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Reason
During routine monitoring of complaints, bsc noted that the intellatip mifi xp n4 complaint rate for distal tip bends/kinks was above the anticipated rate in bsc's product risk documentation.
Action
Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service. The letter identified the affected products, problem and actions to be taken. Customers were instructed to contact their local Sales Representative to answer any questions.