FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1485-2026
- Recalling firm
- Aesculap Inc
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2026-01-15
- Posted
- 2026-03-02
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K983365"]
- PMA numbers
- not on file
- Product code
- GWG
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28