Respire Medical recalls Pink H/S Oral Sleep Apnea Devices due to potential breakage during use. Affected units have serial number 46299. Stop using immediately if you own this model.
Potential for device breakage during use
Respire Medical is recalling its Pink H/S Oral Sleep Apnea Device because it can break during use. This breakage risk could lead to injury or device failure while wearing it.
The device can break during normal use, which may cause injury or device failure. Breakage could happen while the device is in use, leading to potential harm.
People using the Respire Pink H/S Oral Sleep Apnea Device are affected. Those who wear the device during sleep are most at risk due to potential breakage.
Check for the serial number 462:99 on the device. This model was sold by Respire Medical.
If you own this device, stop using it right away to avoid potential breakage.
Yes, the device can break during use, which may cause injury or device failure.
Stop using it immediately and contact Respire Medical for further instructions.
Look for the serial number 46299 on the device. This model was sold by Respire Medical.
We’ve drafted a message you can send Respire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1950-2018 — Respire Medical Respire Medical Hello, I own a Respire Medical that is covered by recall Z-1950-2018 from Respire 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.
