BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-1485-2026 · Reported March 11, 2026

    Enforcement

    Recall Number
    Z-1485-2026
    Event ID
    98301
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2026
    Initiation Date
    January 15, 2026
    Classification Date
    March 2, 2026
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    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

    Reason

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

    Code Info

    Mode No. FF399R; UDI-DI 04038653065547; Serial Numbers: 4595, 4619, 4657, 4764, 4592, 4596, 4598, 4601, 4606, 4607, 4608, 4612, 4616, 4618, 4620, 4621, 4623, 4659, 4661, 4662, 4667, 4670, 4673, 4674, 4688, 4689, 4746, 4748, 4757, 4758, 4760, 4761, 4762, 4767, 4768, 4771, 4773, 4774, 4779, 4780, 4784, 4786, 4789, 4791, 4792, 4795, 4799, 4811, 4812, 4818, 4819, 4821, 4822, 4824, 4825, 4826, 4827, 4836, 4838, 4841, 4842, 4843, 4854, 4856, 4858, 4864, 4868, 4869, 4880, 4882, 4886, 4890, 4891, 4892, 4893, 4899, 4901, 4902, 4907, 4914, 4921, 4927, 4940, 4951, 4959, 4967, 4968, 4970, 4971, 4972, 4973, 4974, 4975, 4976, 4990, 4994, 4995, 5000, 5004, 5015, 5024, 5035, 5036, 5042, 5057, 5058, 5059, 5062, 5063, 5064, 5072, 5076, 5081, 5084, 5106, 5112, 5115, 5117, 5118, 5119, 5121, 5123, 5165, 5166, 5168, 5172;

    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.

    Quantity

    126 units