Sun Med recalls adult manual resuscitators with medium adult masks that may detach during use, risking air delivery failure. Affected units include specific lot numbers.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Sun Med is recalling adult manual resuscitators with medium adult masks due to a risk that the patient port may detach during use, potentially interrupting air delivery to patients. This could lead to serious injury if the device fails during an emergency.
The patient port retaining ring may not fully seat, causing the port to detach during use. This could interrupt air delivery to a patient, which is critical during emergency resuscitation attempts.
Healthcare professionals using the recalled resuscitators are most at risk, particularly during emergency medical situations where air delivery is critical.
Check for the model name 'MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING' and lot numbers listed: 313298, 313516, 313588, 313589, 313058, 313060, 313125, 313173, 313297, 313714, 313715, and 313774.
Identify the lot number on the device to confirm if it is in the affected list: 313298, 313516, 313588, 313589, 313058, 313060, 313125, 313173, 313297, 313714, 313715, or 313774.
The patient port retaining ring may not fully seat, causing the port to detach during use and potentially interrupting air delivery to patients.
Check the lot number on the device to see if it is in the affected list. If it is, contact Sun Med for further instructions.
Yes, if the device detaches during use, it could interrupt air delivery to a patient, which is critical during emergency resuscitation.
We’ve drafted a message you can send Sun Med to request your refund or repair — edit it as you like.
Subject: Recall Z-2146-2018 — Sun Med Sun Med Hello, I own a Sun Med that is covered by recall Z-2146-2018 from Sun Med. 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.