Recalls / —

—#214060

Product

Extended Tip Applicator, 15 CM, Box of 5.

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K091315

Affected lot / code info

Model/Catalog Number: 205115; UDI: 10381780000150; All Lots.

Why it was recalled

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Root cause (FDA determination)

Process change control

Action the firm took

An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification dated 5/22/25 was mailed to consignees for this product removal. Consignees are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at FCA2@integralife.com or by FAX at 1-609-750-4220. The provided notification is to be forwarded to users of affected devices and a copy retained for consignee records. A Return Material Authorization number will be generated upon receipt of the Acknowledgment Form for credit. Sales Representatives and Distributors are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at FCA2@integralife.com or by FAX at 1-609-750-4220. Distributors who further distributed affected devices are to forward the provided notification to their customers and collect Acknowledgement forms on their behalf to submit to Integra. Sales Representatives will be contacted by Post Market Quality to coordinate return of devices. Consignees with any questions are to contact Customer Service by phone at 1-800-654-2873 or by email at custsvcnj@integralife.com. Additional communications were made to customers on 7/10/25 and 7/18/25 informing them that expired devices are also subject to this recall and should be disposed of.

Recalling firm

Firm

Integra LifeSciences Corp. (NeuroSciences)

Address

1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.

Timeline

Recall initiated

2025-05-22

Posted by FDA

2025-06-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.