Lower riskMedical device recall · FDA · Published May 14, 2021
Smiths Medical PORTEX Tracheostomy Kit Recall: Incorrect Labeling Risk
Smiths Medical recalls a specific tracheostomy kit model due to incorrect labeling that could lead to improper use in medical settings. Affected units may have been mislabeled as 7.0mm when they are 9.0mm.
“Smiths Medical PORTEX Tracheostomy Kit Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62544-smiths-medical-portex-tracheostomy-kit-recall-incorrect-labeling-risk. Based on FDA recall #Z-1993-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2021%22&limit=1).
Smiths Medical ASD Inc. recalled one lot of PORTEX ULTRAperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090, after the FDA announced the Class II recall on May 14, 2021. The hazard involves a specific 9.0mm kit being incorrectly labeled as a 7.0mm ID kit.
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit, according to the FDA recall record.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls of similar products include Medline TRACH TUBE KIT Recall (July 10, 2026), Medline Convenience Kits Recall (Jan. 7, 2026), and Covidien Shiley Tracheostomy Tube Recall (April 15, 2026).
How to tell if you have this one
Check the lot number on the kit packaging. The affected model has a lot number of 4072715 and is labeled as a 9.0mm kit but may have been incorrectly labeled as 7.0mm.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Label
Verify the lot number and internal diameter size on the kit packaging. The affected lot is 4072715.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of PA, MI, MD, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Maryland, Michigan, Pennsylvania.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1993-2021 (May 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1993-2021 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.