Stop using now Medical device recall · FDA · Published November 5, 2018

Covidien 8Fr Safe Grad Cat W/Valve Recall: Import Refusal Hazard

Covidien recalls 8Fr Safe Grad Cat W/Valve (Argyle Suction Catheter Kits with Chimney Valve) Model 36826 due to import refusal. Affected units sold with Lot 1816211: stop using immediately.

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

🇺🇸 FDA recall #Z-0656-2019Medical device Covidien ›

Stop using this now

The product was released into commercial distribution while subject to importation refusal.

Take action

Contact the company

Recalling firmCOVIDIEN LLC15 Hampshire St · Mansfield, MA 02048-1113

✎ GovInfoNow plain-language explainer

Covidien is recalling a specific type of suction catheter kit because it was released into the market while under import refusal. This means the product may not be safe for use and should be stopped immediately. Read more at govinfonow.com/recall/69499-covidien-8fr-safe-grad-cat-w-valve-recall-import-refusal.

Source Summary by GovInfoNow · govinfonow.com/recall/69499-covidien-8fr-safe-grad-cat-w-valve-recall-import-refusal · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0656-2019

Cite this page

“Covidien 8Fr Safe Grad Cat W/Valve Recall: Import Refusal Hazard.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69499-covidien-8fr-safe-grad-cat-w-valve-recall-import-refusal. Based on FDA recall #Z-0656-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0656-2019%22&limit=1).

The FDA announced on 2018-11-05 that Covidien LLC voluntarily recalled 32,071 units of 8Fr SAFE GRAD CAT W/Valve suction catheter kits because they were distributed while subject to importation refusal. The recall, classified as Class II, has been terminated.

How to tell if you have it

Brand: Covidien
Product: Argyle Suction Catheter Kits with Chimney Valve (8Fr SAFE GRAD CAT W/Valve)
Model Number: 36826
Lot Number: 1816211264

The hazard

According to the FDA, the hazard is that the product was released into commercial distribution while subject to importation refusal.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2026-05-13. Other recent recalls of similar products include Covidien EndoFLIP System (2026-05-13), Covidien Shiley Disposable Decannulation Plug (2026-04-23), and Covidien Mon-a-Therm Temperature Probe (2026-04-23). Additional similar recalls include Covidien EndoStitch Polysorb Loading Unit (2026-04-15), Covidien V-Loc 90 Wound Closure Device (2026-06-24), and Covidien V-Loc 180 Absorbable Wound Closure Device (2026-06-24).

How to tell if you have this one

Check for the model number 36826 on the product. The lot number 1816211264 is also associated with this recall.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard the product if you have the model number 36826 with lot number 1816211264.

Where it went and when

Where it was distributed

Distributed in 36 states.

FDA distribution: “The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Nov 5, 2018Firm started the recall
Dec 20, 2018FDA classified it Class II
Dec 26, 2018Published in FDA’s Enforcement Report
Aug 14, 2020FDA terminated the recall

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/69499-covidien-8fr-safe-grad-cat-w-valve-recall-import-refusal">Covidien 8Fr Safe Grad Cat W/Valve Recall: Import Refusal Hazard (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-0656-2019 (November 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0656-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.