Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff: Manufacturing Error Risk
Shiley recalls adult flexible tracheostomy tubes with TaperGuard Cuff and cuffless models due to a manufacturing error causing smaller than specified connectors, which can lead to respiratory failure or bleeding if not securely connected.
Use caution until it’s fixed
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
Contact the company
What happened, in plain English
Shiley is recalling adult flexible tracheostomy tubes with TaperGuard Cuff and cuffless models because a manufacturing error resulted in connectors that are too small. This can cause unsecure connections with 15mm components, potentially leading to respiratory failure, dyspnea, treatment delays, tissue injury, or bleeding. Read more at govinfonow.com/recall/58662-shiley-adult-flexible-tracheostomy-tube-with-taperguard-cuff-manufacturing-error.
Source Summary by GovInfoNow · govinfonow.com/recall/58662-shiley-adult-flexible-tracheostomy-tube-with-taperguard-cuff-manufacturing-error · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1357-2023
Cite this page
“Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff: Manufacturing Error Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58662-shiley-adult-flexible-tracheostomy-tube-with-taperguard-cuff-manufacturing-error. Based on FDA recall #Z-1357-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1357-2023%22&limit=1).
Why it’s dangerous
The tubes have a manufacturing error that results in connectors smaller than the specified diameter. This can cause loose connections with 15mm caps and other components, which may lead to respiratory failure, dyspnea, treatment delays, tissue injury, or bleeding if not properly secured.
Who’s affected
Patients using Shiley adult flexible tracheostomy tubes with TaperGuard Cuff or cuffless models are most at risk. Healthcare providers and caregivers who use these tubes daily should also be cautious.
How to tell if you have this one
Check for the product codes listed in the recall: 10CN10H, 10CN10R, 10UN10A, 10UN10H, 10UN10R, 4CN65A, 4CN65H, 4CN65R, 4UN65A, 4UN65H, 4UN65R, 5CN70A, 5CN70H, 5CN70R, 5UN70A, 5UN70H, 5UN70R, 6CN75A, 6CN75H, 6CN75R, 6UN75H, 6UN75R, 7CN80A, 7CN80H, 7CN80R, 7UN80A, 7UN80H, 7UN80R, 8CN85A, 8CN85H, 8CN85R, 8UN85A, 8UN85H, 8UN85R, 9CN90H, 9CN90R, 9UN90H, 9UN90R. These models were sold with specific lot numbers and reference codes.
- Brand
Shiley- Category
Medical device
What to do — step by step
Check Product Details
Identify your tube model and lot number by checking the product codes listed in the recall notice.
Contact Manufacturer
Reach out to Shiley directly for assistance with the recall and to confirm if your specific model is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of PR, CA, FL, MN, PA, AZ, IL, TN, OH, MI, GA, KS, HI, MD, AK, NY, NE, IA, OK, VA, ND, MO, NC, SC, KY, OR, IN, WA, TX, WI, CT, MA, WV, CO, VT, NJ, SD, AR, AL, MS, LA, DE, MT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- 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-1357-2023 (March 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1357-2023 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.