Use cautionMedical device recall · FDA · Published June 7, 2024
Integra AURORA Surgiscope System Recall: Potential Tissue Damage Risk
Integra LifeSciences recalls AURORA Surgiscope System due to potential sheath damage causing tissue injury or bleeding. Affected units have specific model and lot numbers.
“Integra AURORA Surgiscope System Recall: Potential Tissue Damage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54916-integra-aurora-surgiscope-system-recall-potential-tissue-damage-risk. Based on FDA recall #Z-2331-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2331-2024%22&limit=1).
Integra LifeSciences Corp. recalled the AURORA Surgiscope System due to potential sheath damage that could lead to tissue damage or track hemorrhage, according to the FDA on June 7, 2024.
How to tell if you have it
Brand: Integra LifeSciences
Product: AURORA Surgiscope System
Model No.: ASX9/130
UDI#: 00850002332278
Lot No.: 7336314
The hazard
The sterile, single-use device contains a Sheath, Obturator, and Imager. Potential sheath damage could lead to tissue damage and/or track hemorrhage.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since 2017-08-18. Other recent recalls of similar products include Integra AURORA Surgiscope System Recall (2025-02-06), MediHoney Wound Dressing Gel Recall (2025-01-10), and Integra LifeSciences CODMAN CERTAS Plus Valve Recall (2024-12-16). Other recent recalls of similar products include Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (2026-07-09), Oscor Abiomed Introducer Kit Recall (2026-06-10), and Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03).
How to tell if you have this one
Check for model number ASX9/130 and lot number 7336314 on the device packaging or label. The device includes a Sheath, Obturator, and Imager components.
Brand
Integra LifeSciences
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Components
Verify the device includes a Sheath, Obturator, and Imager components with model number ASX9/130 and lot number 7336314.
Where it went and when
Where it was distributed
Distributed in D.C., New York and Ohio.
Listed by the agency
Not listed
FDA distribution: “Domestic: NY, OH, & DC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: District of Columbia, New York, Ohio.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2331-2024 (June 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2331-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.