HIGH

Aesculap MINOP TROCAR 150MM Recall for 126 Units in 2026

Aesculap recalls 126 MINOP TROCAR 150MM devices distributed nationwide to U.S. hospitals and clinics after regulators flagged a shaft length issue. The shaft may be longer than specified, potentially harming tissue during procedures. Healthcare facilities should stop using the devices and follow manufacturer recall instructions immediately.

Quick Facts at a Glance

Recall Date
January 15, 2026
Hazard Level
HIGH
Brand
Aesculap
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aesculap Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

MINOP TROCAR is a laparoscopic access device used in surgery to create ports in the abdominal wall during procedures.

Why This Is Dangerous

An excessively long shaft may extend beyond intended length, increasing risk of tissue injury during insertion or manipulation.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals must halt use of the affected trocars and coordinate returns or replacements with the vendor.

Practical Guidance

How to identify if yours is affected

  1. Check model FF399R and UDI 04038653065547
  2. Review Serial Numbers: 4595,4619,4657,4764,4592,4596,4598,4601,4606,4607,4608,4612,4616,4618,4620,4621,4623,4659
  3. Compare to labeling on device and packaging to confirm match

Where to find product info

Serial numbers on the device label and packaging; UDI on the box

What timeline to expect

Remedy processing may take 4-8 weeks after request

If the manufacturer is unresponsive

  • Document all communications with the manufacturer
  • Escalate to FDA recall office if needed
  • File a report with the CPSC if applicable to medical devices (consult hospital compliance)

How to prevent similar issues

  • Ensure purchase from authorized distributors
  • Request UDI and serial numbers before use
  • Monitor recall notices on FDA and manufacturer sites
  • Verify shaft measurements during instrument setup

Documentation advice

Keep recall notices, serial numbers, photos of labeling, and all correspondence with the manufacturer

Product Details

Model/Catalog Number: FF399R. Product: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM. Serial Numbers: 4595, 4619, 4657, 4764, 4592, 4596, 4598, 4601, 4606, 4607, 4608, 4612, 4616, 4618, 4620, 4621, 4623, 4659. Quantity: 126 units. Distribution: US nationwide in 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. Recall Date: 2026-01-15. Status: ACTIVE. Class: II. Remedy: Stop using and contact Aesculap Inc or healthcare provider for instructions. UDI-DI: 04038653065547.

Key Facts

  • 126 units recalled
  • Model FF399R; Serial numbers include 4595, 4619, 4657, 4764, 4592, 4596, 4598, 4601, 4606, 4607, 460
  • 8, 4612, 4616, 4618, 4620, 4621, 4623, 4659
  • UDI-DI 04038653065547
  • Distributed nationwide in 30+ states
  • Recall date 2026-01-15; status ACTIVE

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
LACERATIONOTHER

Product Details

Model Numbers
FF399R
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
Affected States
ALL
Report Date
March 11, 2026
Recall Status
ACTIVE

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