Recall Z-1485-2026 ยท GWG Endoscope, Neurological
Aesculap Inc
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
| Date | Mar 2, 2026 (initiated Jan 15, 2026) |
| Status | Open, Classified |
| Reason | There is the potential for the length of the trocar shaft to be too long. |
| Root cause | Under Investigation by firm |
| Action | on January 28, 2026 URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters were sent to customers. Actions to be taken: - Review the attachment Aesculap AG Urgent Field Safety Notice in its entirety. - If it is determined that a portion of the visual field is obscured, the manufacturer recommends rotating the device to compensate for the restricted view (refer to the attached Urgent Field Safety Notice from the manufacturer). Note: Devices are not being removed from the market, this is a field notification. - Return the completed Urgent Medical Device Correction Acknowledgement Form to Ae |
| Quantity | 126 units |
| Distribution | US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983365 | AESCULAP MINOP SYSTEM Aesculap, Inc., Dec 18, 1998 |