Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Recalled by Stryker Sustainability Solutions Due to Through investigation, it was determined that H12LP Trocars...

Date: June 19, 2018
Company: Stryker Sustainability Solutions
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Sustainability Solutions directly.

Affected Products

Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Quantity: 4848

Why Was This Recalled?

Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Sustainability Solutions

Stryker Sustainability Solutions has 38 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report