Aesculap Inc. Recalls MINOP Trocar Devices Due to Incorrect Shaft Length
Aesculap Inc. has issued a voluntary recall for 126 MINOP Trocar units because the trocar shaft may be too long, posing a potential risk during surgical procedures.
What Happened
Aesculap Inc. has initiated a voluntary recall of its MINOP Trocar 150mm devices. The recall was prompted by the discovery that the length of the trocar shaft has the potential to be longer than the specified design requirements. This manufacturing defect was identified by the firm and communicated to the FDA.
Which Products Are Affected
The recall affects 126 units of the following medical device:
- Brand Name: AESCULAP
- Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL 6.0MM
- Model/Catalog Number: FF399R
- UDI-DI: 04038653065547
- Recall Number: Z-1485-2026
- Serial Numbers: 4595, 4619, 4657, 4764, 4592, 4596, 4598, 4601, 4606, 4607, 4608, 4612, 4616, 4618, 4620, 4621, 4623, 4659, 4661, 4662, 4667, 470, 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.
The affected units were distributed nationwide across the following states: 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, and WA.
What You Should Do
Aesculap Inc. initiated the recall on January 15, 2026, by sending notification letters to affected customers. Healthcare facilities and distributors should immediately check their inventory for the model and serial numbers listed above. If affected products are found, they should be quarantined and handled according to the instructions provided in the firm’s notification letter.
Why This Matters
A trocar shaft that is longer than intended could lead to unintended contact with internal tissues or organs during surgical procedures, potentially causing injury to the patient. The FDA has classified this as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences.
Source
This information is based on official recall data provided by the FDA.
Source: FDA Official Notice