SunMed recalls adult resuscitators with medium masks that have B/V filters incorrectly attached to patient ports. This may cause delays in resuscitation, leading to hypoxia or death. Affected lots include specific serial numbers.
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
SunMed is recalling adult manual resuscitators with medium masks that have a filter attached to the wrong port. If not noticed before use, this can delay life-saving treatment and cause serious harm or death.
The filter is attached to the patient port instead of the exhalation port. This causes interruptions in oxygen delivery during resuscitation, which can lead to hypoxia, hypercapnia, organ failure, or death if not corrected.
Healthcare professionals using the resuscitator for emergency medical care. Those with the specific serial numbers listed in the recall are most at risk.
Check the serial numbers on the product: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 526807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, 526818. The product includes a medium adult mask, bag reservoir, filter, manometer, and 7 ft oxygen tubing.
Immediately stop using the resuscitator if it has the affected serial numbers listed in the recall.
The B/V filter is attached to the patient port instead of the exhalation port, which can cause interruptions in oxygen delivery during resuscitation.
The affected serial numbers are: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 526807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, 526818.
The recall record does not mention any remedy or replacement options.
We’ve drafted a message you can send SunMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1814-2025 — SunMed SunMed Hello, I own a SunMed that is covered by recall Z-1814-2025 from SunMed. 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.
