Recall Z-1958-2025— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1958-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-22

Class I · Ongoing

Class I FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2025-05-22. It names one FDA 510(k) clearance: K091315. Product: Extended Tip Applicator, 8CM, Box of 5.. Reason: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class I
Status: Ongoing
Initiated: 2025-05-22
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K091315 — COVIDIEN EXTENDED TIP APPLICATORConfluent Surgical,Inc·cleared 2009-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Extended Tip Applicator, 8CM, Box of 5.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.