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.
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.
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.
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.
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.
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.
Identify your tube model and lot number by checking the product codes listed in the recall notice.
Reach out to Shiley directly for assistance with the recall and to confirm if your specific model is affected.
The affected models include 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, and 9UN90R.
The recall does not specify a remedy, so contact Shiley directly to determine if your specific model is affected and to get guidance on next steps.
Yes, the manufacturing error can cause unsecure connections with 15mm components, potentially leading to respiratory failure, dyspnea, treatment delays, tissue injury, or bleeding.
We’ve drafted a message you can send Shiley to request your refund or repair — edit it as you like.
Subject: Recall Z-1357-2023 — Shiley Shiley Hello, I own a Shiley that is covered by recall Z-1357-2023 from Shiley. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
