Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ventlab Recalled by SunMed Holdings, LLC Due to A backwards leak present in the integrated manometer...
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
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.
Quantity: N/A
Why Was This Recalled?
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
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