Aesculap Inc recalls Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Cata…
Reason for recall
There is the potential for the length of the trocar shaft to be too long.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 04038653065547
- Serial #
4595, 4619, 4657, 4764, 4592, 4596 — +120 moreShow all
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
What the firm is doing
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
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1485-2026
- FDA 510(k) clearance · K983365The device's official FDA premarket clearance record
- FDA device classification · GWGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 882.1480The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Aesculap IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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