Class II — Potential Health Hazard

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

Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical Recalled by Covidien Due to Investigations related to customer complaints received for particulate...

Date: March 5, 2021
Company: Covidien
Status: Ongoing
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 Covidien directly.

Affected Products

Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

Quantity: 59,828 devices

Why Was This Recalled?

Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.

Where Was This Sold?

This product was distributed to 36 states: AL, AK, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, MO, NE, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TX, UT, WA, WV, WI

Affected (36 states)Not affected

About Covidien

Covidien has 21 total recalls tracked by RecallDetector.

Related Recalls

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