Covidien Shiley Lo-Pro Tracheal Tube Recall: Potential Leaks in Inflation System
Covidien recalls Shiley Lo-Pro Oral/Nasal Tracheal Tubes with potential leaks in the cuffed inflation system. Affected units include model REF 86051, 7.0 mm I.D. with specific lot numbers. Contact for replacement or return.
Stop using this now
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Contact the company
What happened, in plain English
Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes that may leak due to the cuffed inflation system. This could lead to airway complications during medical procedures. Patients and healthcare providers using these tubes should stop using them immediately. Read more at govinfonow.com/recall/58916-covidien-shiley-lo-pro-tracheal-tube-recall-potential-leaks-in.
Source Summary by GovInfoNow · govinfonow.com/recall/58916-covidien-shiley-lo-pro-tracheal-tube-recall-potential-leaks-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1318-2023
Cite this page
“Covidien Shiley Lo-Pro Tracheal Tube Recall: Potential Leaks in Inflation System.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58916-covidien-shiley-lo-pro-tracheal-tube-recall-potential-leaks-in. Based on FDA recall #Z-1318-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1318-2023%22&limit=1).
Why it’s dangerous
The cuffed inflation system in these tubes may leak, which could cause airway complications during medical procedures. Leaks might lead to inadequate airway protection or other serious issues if the tube is used improperly.
Who’s affected
Healthcare providers and patients who use the Shiley Lo-Pro Oral/Nasal Tracheal Tubes for medical procedures are affected. Those with the specific model and lot numbers are at highest risk.
How to tell if you have this one
Check for the model number REF 86051 with a 7.0 mm I.D. on the tube. Affected units have lot numbers 22G0343JZX or 22G0344JZX.
- Brand
Covidien- Category
Medical device
What to do — step by step
Stop Using It Now
Immediately stop using the Shiley Lo-Pro Oral/Nasal Tracheal Tube if it has the model number REF 86051 and lot numbers 22G0343JZX or 22G0344JZX.
Where it went and when
Where it was distributed
Distributed in 25 states, and outside the U.S.
FDA distribution: “U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, West Virginia.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1318-2023 (February 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1318-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.