Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version

FDA device recall Z-1485-2026 · posted 2026-03-02 · Open, Classified

Recall details

Recalling firm

Aesculap Inc

Reason for recall

There is the potential for the length of the trocar shaft to be too long.

Action taken

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 Aesculap, Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt. Action planned by Aesculap AG to correct the problem: To address this issue, the manufacturer is implementing additional inspections of the optical system and introducing clearly defined acceptance criteria, along with other corrective actions. Should there be any questions, comments, or concerns regarding the product you have received, please feel free to contact (844-903-6417) or recalls@bbraunusa.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GWG

Quantity affected

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.

Date initiated

2026-01-15

Date posted

2026-03-02

Location

Center Valley, PA

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