Covidien Shiley Tracheostomy Tube Recall Due to Labeling Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Covidien LLC is recalling 1,002 COVIDIEN Shiley Tracheostomy Tubes (REF 6FEN) due to incorrect display box labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 10, 2026 and geographically references Texas, United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Covidien LLC initiated a recall due to a customer complaint regarding incorrect display box labeling.
Which Products Are Affected
The recall involves COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN with UDI-DI code 60884522007028, Lot Number 25H0868JZX. A total of 1,002 units are affected. Distribution includes the state of TX in the U.S. and the countries of France, French Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
The recall affects devices intended for providing tracheal access for airway management.
Source
FDA recall number Z-2261-2026, Class II, event ID 98813.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (753 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.