Smiths Medical UniPerc Tracheostomy Tube Kit Recall: Incorrect Obturator Size
Smiths Medical recalls UniPerc Adjustable Flange Tracheostomy Tube kits with incorrect 9.0mm obturator (lot 3308971). This could cause improper tube fitting during medical procedures.
Lower-risk recall
Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
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What happened, in plain English
Smiths Medical is recalling a specific lot of UniPerc Adjustable Flange Tracheostomy Tube kits because they contain a 9.0mm obturator instead of the required 8.0mm size. Using these tubes could lead to improper fitting during medical procedures, potentially causing complications. Read more at govinfonow.com/recall/73144-smiths-medical-uniperc-tracheostomy-tube-kit-recall-incorrect-obturator-size.
Source Summary by GovInfoNow · govinfonow.com/recall/73144-smiths-medical-uniperc-tracheostomy-tube-kit-recall-incorrect-obturator-size · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3213-2017
Cite this page
“Smiths Medical UniPerc Tracheostomy Tube Kit Recall: Incorrect Obturator Size.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73144-smiths-medical-uniperc-tracheostomy-tube-kit-recall-incorrect-obturator-size. Based on FDA recall #Z-3213-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3213-2017%22&limit=1).
Why it’s dangerous
The incorrect 9.0mm obturator can cause improper tube fitting during medical procedures. This may lead to complications such as improper stoma placement or tube displacement if the tube is not properly sized for the patient's neck.
Who’s affected
Patients using the recalled UniPerc Tracheostomy Tube kits with lot number 3308971 are most at risk. Healthcare providers who have purchased this specific lot for medical use may also be affected.
How to tell if you have this one
Check for lot number 3308971 on the UniPerc Adjustable Flange Tracheostomy Tube kit packaging. The product was sold with reorder number 100/897/080 CZ.
- Brand
Smiths Medical- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for lot number 3308971 on the UniPerc Adjustable Flange Tracheostomy Tube kit packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-3213-2017 (August 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3213-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.