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# Integra Recalls Surgical Applicators Over Sterility Issues
- URL: https://www.fdaweb.com/integra-recalls-surgical-applicators-over-sterility-issues/
- Published: 2025-08-28T12:00:00.000Z
- Updated: 2026-09-14T15:20:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159781

Integra LifeSciences is recalling (Class 1) its Extended Tip Applicators because the products may have high levels of harmful substances and may not have gone through a fully documented sterilization process. “Use of the affected product may cause serious adverse health consequences, including inflammation, infection, and death,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/applicator-recall-integra-lifesciences-removes-extended-tip-applicator-due-potential-sterility-and?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. To date, there have been no reported injuries or deaths related to this issue.

The applicators are sterile, single-use devices used for precise application of medical substances during surgical procedures, the notice says. They are commonly used in operating rooms and are packaged in lengths of 8 cm and 15 cm.