Manual resuscitators recalled due to carbon dioxide rebreathing defect
SunMed Holdings recalls Ventlab STAT-Check manual resuscitators due to a backwards leak in the integrated manometer allowing CO2 rebreathing, which may impair ventilation. Multiple models (Adult, Infant, Pediatric) are affected and distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a functional defect in respiratory equipment. The backwards leak in the manometer causes CO2 rebreathing, which could impair ventilation during resuscitation. This merits a High severity score per the rubric criteria for risk-of-harm products in life-support equipment.
Plain-English summary
Ventlab, LLC STAT-Check manual resuscitators are being recalled by manufacturer SunMed Holdings, LLC. The recalled devices include the Adult Resuscitator (REF #SC9101B), Infant Resuscitator (REF #s SC7101B and SC7101B-M0), and Pediatric Resuscitator (REF #SC8121B).
A backwards leak has been identified in the integrated manometer of the patient valve. This defect allows exhaled carbon dioxide to be rebreathed by the patient, which can impair the effectiveness of manual ventilation and patient gas exchange.
The affected resuscitators were distributed nationwide, including in 29 U.S. states. All units manufactured from September 21, 2018 through the present are included in the recall, with the latest expiration date of October 11, 2028. This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator R
- Manufacturer
- SunMed Holdings, LLC
- Hazard
- co2-rebreathing
- equipment-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- UDI-DI: 10889483109250
- (Item # SC7101B
- Case UDI: 30889483109254)
- UDI-DI: 10889483160671
- (Item # SC7101B-M0. Case UDI: 30889483160675)
- UDI-DI: 10889483110041
- (Item # SC8121B
- Case UDI: 30889483110045)
- UDI-DI: 10889483098677
- (Item # SC9101B
Distribution
Distributed nationwide across the United States.
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