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Use caution Medical device recall · FDA · Published February 13, 2025

Smiths Medical Portex Endotracheal Tube Recall: Risk of Inadequate Ventilation

Smiths Medical recalls Portex Endotracheal Tubes with specific item codes due to potential inadequate ventilation causing hypoxia or cardiopulmonary collapse.

🇺🇸 FDA recall #Z-1289-2025Medical deviceSmiths Medical ›
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Contact the company

Recalling firmSmiths Medical ASD, Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer

Smiths Medical is recalling certain Portex Endotracheal Tubes that may not provide adequate ventilation, risking hypoxia or cardiopulmonary collapse in patients. This recall affects specific item codes and lot numbers. Read more at govinfonow.com/recall/52877-smiths-medical-portex-endotracheal-tube-recall-risk-of-inadequate-ventilation.

Source Summary by GovInfoNow · govinfonow.com/recall/52877-smiths-medical-portex-endotracheal-tube-recall-risk-of-inadequate-ventilation · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1289-2025

Cite this page

“Smiths Medical Portex Endotracheal Tube Recall: Risk of Inadequate Ventilation.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52877-smiths-medical-portex-endotracheal-tube-recall-risk-of-inadequate-ventilation. Based on FDA recall #Z-1289-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2025%22&limit=1).

The FDA announced on Feb. 13, 2025, that Smiths Medical ASD, Inc. is recalling Portex Endotracheal Tubes due to a smaller-than-expected diameter that may cause inadequate ventilation. Affected devices pose a risk of hypoxia, underdose, or cardiopulmonary collapse. Owners should contact the company for a replacement.

How to tell if you have it

  • Brand: Smiths Medical
  • Product: Portex Endotracheal Tube
  • Item Codes: 100/105/025, 100/105/030, 100/105/035, 100/111/020, 100/111/025, 100/111/030, 100/111/035, 100/126/025, 100/126/030, 100/126/035, 100/127/025, 100/127/030, 100/127/035, 100/141/025, 100/141/030, 100/141/035
  • Distribution: Worldwide and US Nationwide

The hazard

The affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patients may experience hypoxia, underdose, or cardiopulmonary collapse.

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 Smiths Medical CADD-Solis Infusion Pumps (April 10, 2025), Smiths Medical CADD-Solis VIP Infusion Pump Recall (April 10, 2025), and Smiths Medical CADD Solis HSPCA Pump (April 10, 2025). Other recent recalls of similar products include Medline Oxygen Masks Recall (Nov. 21, 2025), Medline Intubation Tray Recall (Dec. 24, 2025), and Erbe Medical ERBEFLO 2 Endoscopy Pump Tubing Recall (March 31, 2026).

How to tell if you have this one

Check the item codes on the tube (100/105/025, 100/105/030, etc.) and lot numbers listed in the recall. The tubes are used in medical settings for patient ventilation.

  • Brand
    Smiths Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Item Codes

    Look for specific item codes on the tube, such as 100/105/025 or 100/111/020.

  2. Contact Manufacturer

    Reach out to Smiths Medical for assistance with the recall if you have the affected item codes.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Feb 13, 202512. FDA classified it Class I: Mar 12, 202523. Published in FDA’s Enforcement Report: Mar 19, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using these tubes immediately?

No, but you should check the item codes and lot numbers to determine if your tube is affected. The recall does not require immediate discontinuation.

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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-1289-2025 (February 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1289-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA