Has Integra LifeSciences Corp. (NeuroSciences) had other FDA enforcement actions?

Yes. Argus HQ has recorded 8 total FDA actions tied to Integra LifeSciences Corp. (NeuroSciences): 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-15; Argus observed and indexed it on 2026-07-23.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Integra LifeSciences Corp. (NeuroSciences) — Class II recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product co…

Name: FDA Recall Record — Integra LifeSciences Corp. (NeuroSciences)
Creator: Argus HQ
Published: 2026-07-15
License: https://argushq.ai/methodology

Event date: 2026-07-15 00:00:00Z
Observed: 2026-07-23 04:20:41Z
Source ID: Z-2714-2026
Payload hash: d19583dd42137bc4cb12f41a…

Summary

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. Status: Ongoing.

Entities

Integra LifeSciences Corp. (NeuroSciences)

View source record ↗

Frequently asked questions

Has Integra LifeSciences Corp. (NeuroSciences) had other FDA enforcement actions?: Yes. Argus HQ has recorded 8 total FDA actions tied to Integra LifeSciences Corp. (NeuroSciences): 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-15; Argus observed and indexed it on 2026-07-23.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Integra LifeSciences Corp. (NeuroSciences) — Class II recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product co…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-integra-lifesciences-corp-neurosciences-z-2714-2026

MLA

"Integra LifeSciences Corp. (NeuroSciences) — Class II recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product co…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-integra-lifesciences-corp-neurosciences-z-2714-2026.

Chicago

Argus HQ Research. "Integra LifeSciences Corp. (NeuroSciences) — Class II recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product co…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-integra-lifesciences-corp-neurosciences-z-2714-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_integra_lifesciences_corp_neurosciences_z_2714_2026_2026,
  title = {Integra LifeSciences Corp. (NeuroSciences) — Class II recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product co…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-integra-lifesciences-corp-neurosciences-z-2714-2026},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.