Smiths Medical recalls ORATOR speaking valves for tracheostomy tubes due to potential uncertainty in sterile packaging seal integrity. Affected units include specific model and lot numbers.
Uncertainty in the seal integrity of the sterile packaging.
Smiths Medical is recalling its ORATOR speaking valves for tracheostomy tubes because the sterile packaging might not seal properly. This could lead to contamination or infection if the valve is used without proper sterility.
The sterile packaging for the valve might not seal correctly, which could allow contamination. This poses a risk of infection if the valve is not properly sterilized before use.
Patients using tracheostomy tubes with the ORATOR speaking valve are most at risk. Healthcare providers who use these valves in medical settings may also be affected.
Check for the model number 'ORATOR' and lot numbers 4122013, 4130776, or 4130777 on the packaging. The product is sold by Smiths Medical.
Look for the model number 'ORATOR' and lot numbers 4122013, 4130776, or 4130777 on the packaging.
The recall is due to potential uncertainty in the sterile packaging seal, which could lead to contamination. The product is not safe to use without checking the packaging details.
Check the packaging for the model number and lot numbers. If they match the recalled items, contact Smiths Medical for further instructions.
Look for the model number 'ORATOR' and lot numbers 4122013, 4130776, or 4130777 on the packaging. The product is sold by Smiths Medical.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0146-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0146-2025 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
