This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

What to Do

• Identify any affected products at your facility.
• Remove them from service and quarantine them.
• Discard expired lots.

On May 23, 2025, Integra LifeSciences sent all affected customers an Urgent Voluntary Medical Device Recall letter recommending the following actions:

For customers

• Determine if product you have is subject to the recall based on impacted part and lot number.
• Immediately remove any affected products from service and quarantine.
• Complete the acknowledgment form attached to the letter, even if you do not have affected product.
  • Record the lot number and total quantity of affected product.
  • Send completed acknowledgement form by email to FCA1@integralife.com or fax to 1-609-750-4220.
  • After the acknowledgement form is received, customer service will provide a Return Material Authorization (RMA) number and directions to return affected product. You can request a credit for returned quantities. Note: Credit will only be given for the impacted lot(s) that are returned.
• Keep a copy of the form for your records.
• Forward the notice to people who use the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas.

For distributors/sales representatives

• Determine if product you have is subject to the recall based on impacted part and lot number.
• Remove any affected products from further distribution.
• Complete the acknowledgment form attached to the letter, even if you do not have affected product.
  • Record the lot number and total quantity of affected product.
  • Send completed acknowledgement form by email to FCA1@integralife.com or fax to 1-609-750-4220.
  • After the acknowledgement form is received, customer service will provide a Return Material Authorization (RMA) number and directions to return affected product. You can request a credit for returned quantities. Note: Credit will only be given for the impacted lot(s) that are returned.
• Keep a copy of the form for your records.
• Check customer traceability records for shipments of affected catalog and lot numbers.
• If impacted product was shipped to customers, please:
  • Create an acknowledgement form from you to your customers.
  • Forward a copy of the notice and your acknowledgement form to any customers who purchased affected catalog and lot numbers.
  • Collect completed response forms and affected product from your customers.
  • Indicate total quantities and lots in the distributor reply form provided with the letter.
  • After the acknowledgement form is received, customer service will provide a Return Material Authorization (RMA) number and directions to return affected product. Distributors can request a credit for returned quantities. Note: Credit will only be given for the impacted lot(s) that are returned.
• If you are a sales representative, Post Market Quality will contact you and provide you with directions to return the product after the acknowledgement form has been returned and indicates you have affected product.

Reason for Recall

Integra LifeSciences is recalling MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfer documentation, both of which help ensure the products were effectively sterilized. 

The use of affected product may cause serious adverse health consequences, including inflammation, infection, and death.

Integra LifeSciences has not reported any serious injuries or deaths associated with this issue.

Device Use

The MicroMyst Applicator is intended for use in the delivery of the two DuraSeal precursor solutions onto a surgical site at the same time. It is a sterile, single-use device with a 14 cm, dual lumen, stainless steel cannula and an outer sheath used during surgical procedures.

Contact Information

Customers in the U.S. with questions about this recall should contact their Integra sales representative or customer service at 1-800-654-2873 or custsvcnj@integralife.com

Additional FDA Resources:

FDA’s Enforcement Report
Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.