Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Vers
Summary
The FDA issued a Class II for Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Mod by Aesculap Inc. Reason: There is the potential for the length of the trocar shaft to be too long..
Details
Source
Device Recall
External ID
Z-1485-2026
Action Date
2026-03-11
Status
Ongoing
Category
device
Product 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
Lot/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;
Quantity Affected: 126 units
Reason for Recall
There is the potential for the length of the trocar shaft to be too long.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-15
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Inc has 23 FDA actions in our database, including 18 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Inc have FDA actions?
Aesculap Inc has 23 FDA actions in our database, including 18 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1485-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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