Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Adult Manual Resuscitator with Medium Adult Mask Recalled by SunMed Holdings, LLC Due to Affected lots were manufactured with B/V Filter incorrectly...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SunMed Holdings, LLC directly.
Affected Products
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Quantity: 11,358
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SunMed Holdings, LLC
SunMed Holdings, LLC has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report