Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported July 15, 2015
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing d…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalled Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. … - a critical-severity action.
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. … was recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) in July 15, 2015. Reason: Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the a…. Check the official notice for the remedy. Verify recall #Z-1951-2015 with the FDA Devices before acting.
The recall
Covidien LP (formerly Nellcor Puritan Bennett Inc.) issued this critical-severity FDA Devices recall-Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the a….
- Critical
- severity level
- 69K units
- affected scope
- Class I
- classification
- July 15, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1951-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1951-2015) was formally reported on July 15, 2015, with the manufacturer initiating the action on May 8, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Covidien LP (formerly Nellcor Puritan Bennett Inc.) is listed as the recalling firm, operating out of Boulder, CO. Federal records list the affected scope as 69,461 units total.
The documented reason for this recall is: Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative… Distribution data in the federal record shows the product reached: Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
69,461 units total
Related Recalls
6
3 from same agency
Product description
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Reason for recall
Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1951-2015 |
| Date reported | July 15, 2015 |
| Date initiated | May 8, 2015 |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
| Firm location | Boulder, CO |
| Affected scope | 69,461 units total |
| Distribution | Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1951-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.. Recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.). Units affected: 69,461 units total.
Why was this product recalled? ▼
Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2015. Severity: Critical. Recall number: Z-1951-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1951-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 15, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.