Lower risk Medical device recall · FDA · Published March 5, 2021

Covidien Surgiwand II Suction Device Recall: Particulate Matter Risk

Covidien recalls Surgiwand II suction devices due to particulate matter in tubing from damaged Y-connector during assembly. Affected models include 178083, 178093, 178094.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1411-2021Medical device Covidien ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmCovidien201 Sabanetas Industrial Park, Building 911-67 · Ponce, PR 00716

✎ GovInfoNow plain-language explainer

Covidien is recalling Surgiwand II suction and irrigation devices because a damaged Y-connector during assembly creates particulate matter inside the tubing. This could pose a risk to patients during surgery if particles enter the surgical site. Read more at govinfonow.com/recall/63149-covidien-surgiwand-ii-suction-device-recall-particulate-matter-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63149-covidien-surgiwand-ii-suction-device-recall-particulate-matter-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1411-2021

Cite this page

“Covidien Surgiwand II Suction Device Recall: Particulate Matter Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/63149-covidien-surgiwand-ii-suction-device-recall-particulate-matter-risk. Based on FDA recall #Z-1411-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1411-2021%22&limit=1).

The FDA announced on March 5, 2021, that Covidien is recalling its Surgiwand II Suction and Irrigation Device due to particulate matter hazards. The agency issued recall number Z-1411-2021 for the electrosurgical device.

How to tell if you have it

Brand: Covidien
Product: Surgiwand II Suction and Irrigation Device
Product Number/CFN: 178083, 178093, 178094
GTIN/UPN: 10884523000887, 20884523000884, 10884523000900, 20884523000907, 10884523000917, 20884523000914
Units affected: 59,828 devices

The hazard

The FDA said investigations into customer complaints identified particulate matter inside the device tubing components. The root cause is a damaged Y-Connector component that generates debris during the assembly process connecting the tubing to the device.

Context

GovInfoNow's records show Covidien has had 14 other recalls on record since February 10, 2023. Recent examples include a June 23, 2025 recall of the Bedside SpO2 Monitor for alarm failures and a May 21, 2025 recall of the Newport HT70 Ventilator for shutdown risks. Other recent recalls of similar products include the Surgipro II S8698GX (June 24, 2026) and Dermalon 4-0 Blue 75cm Sutures (June 24, 2026), both citing infection risks from packaging issues.

How to tell if you have this one

Check for product numbers 178083, 178093, or 178094. The device has a UDI-Device Identifier (GTIN/UPN) listed as 10884523000887, 20884523000884, 10884523000900, 20884523000907, 10884523000917, or 20884523000914.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Numbers
Verify if your device has product numbers 178083, 178093, or 178094.

Where it went and when

Where it was distributed

Distributed in 36 states and Puerto Rico, and outside the U.S.

FDA distribution: “Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 47 days after the firm started it.

Mar 5, 2021Firm started the recall
Apr 12, 2021FDA classified it Class II
Apr 21, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63149-covidien-surgiwand-ii-suction-device-recall-particulate-matter-risk">Covidien Surgiwand II Suction Device Recall: Particulate Matter Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1411-2021 (March 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1411-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.