This recall involves removing certain 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
| Catalog Number | Product Name (Description) | UDI-DI | Lots Affected |
|---|---|---|---|
| 205108 | Extended Tip Applicator, 8CM, Box of 5 | 10381780000143 | All expired and unexpired lots |
| 205115 | Extended Tip Applicator, 15CM, Box of 5 | 10381780000150 | All expired and unexpired lots |
| 201108 | Extended Tip Applicator, 8CM, Box of 1 – Japan | 10381780000167 | All expired and unexpired lots |
What to Do
Do not use the affected products. Immediately remove and quarantine unexpired affected products and discard expired affected products.
On May 22, 2025, Integra LifeSciences sent all affected customers a Voluntary Medical Device Recall Notification recommending the following actions:
- Immediately remove and quarantine any unexpired affected product.
- Discard all expired lots.
- Complete and return the Acknowledgment Form to FCA2@integralife.com or fax 1-609-750-4220.
- Forward this notice to all product users and locations where the product may exist.
- Await Return Material Authorization (RMA) instructions from Customer Service.
- Distributors must notify customers and coordinate returns.
Reason for Recall
Integra LifeSciences is recalling the Extended Tip Applicator because the product may have high levels of harmful substances and may not have gone through a fully documented sterilization process to ensure it is safe to use.
Use of the affected product may cause serious adverse health consequences, including inflammation, infection, and death.
There have been no reported injuries or deaths related to this issue.
Device Use
The Extended Tip Applicator is a sterile, single-use device used for precise application of medical substances during surgical procedures. It is commonly used in operating rooms and is packaged in lengths of 8 cm and 15 cm.
Contact Information
Customers in the U.S. with questions about this recall should contact Integra LifeSciences Customer Service at 1-800-654-2873.
Additional FDA Resources (listed in order of most to least recent):
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.
