Class II — Integra LifeSciences Corp.
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. |
| Product | AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. |
| Quantity | 14 units |
| Distribution | Domestic: NY, OH, & DC. |
| Initiated | 2024-06-07 |
| Classified | 2024-07-10 |
| Recall number | Z-2331-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-2331-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94804/
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