Integra LifeSciences Corp. Recall 96216
Description: 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
Integra LifeSciences Corp. Recall 96216 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1295-2025 |
| Event ID | 96216 |
| Event Description | 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 |
| Product Type | Devices |
| 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. |
| Quantity | 623 units |
| Recall Reason | Possibility for the obturator to break (separate). |
| Device Classification | 20250312 |
| Device Code Info | Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots. |
| Center Classification Date | 20250306 |
| Recall Initiation Date | 20250206 |
| Recalling Firm | Integra LifeSciences Corp. |
| Initial Notification | Letter |
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