Recall Z-1295-2025 ยท GWG Endoscope, Neurological
Integra LifeSciences Corp.
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
| Date | Mar 6, 2025 (initiated Feb 6, 2025) |
| Status | Open, Classified |
| Reason | Possibility for the obturator to break (separate). |
| Root cause | Process control |
| Action | On February 6, 2025, URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine them. 2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the lot number(s) and total quantity of the affected product that you have. 3. Forward this notice to those who utilize the product so they are aware of this recall and can identify and quarantine any affected product that m |
| Quantity | 623 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) Rebound Therapeutics, Nov 4, 2020 |