FDA Medical devices recall ·
AURORA Surgiscope System, Sterile, single use device that contains a… recall
- Recall number
- Z-1295-2025
- Date
- (initiated February 6, 2025)
- Company / brand
- Integra LifeSciences Corp.
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 623 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Why was it recalled?
Possibility for the obturator to break (separate).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots.
Distribution
US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.
States: California District of Columbia Florida Illinois Kentucky Louisiana Maryland Michigan Minnesota Missouri North Carolina New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Tennessee Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1295-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.