RescuMed Manual Resuscitators Recalled for CO2 Rebreathing Risk
SunMed Holdings recalls RescuMed manual resuscitators due to a backwards leak in the manometer allowing CO2 rebreathing. Affected models distributed nationwide across 32 US states.
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: This is a Class II recall of critical emergency medical equipment with a real design defect (backwards leak enabling CO2 rebreathing) that could impair patient ventilation. Although no illnesses or injuries have been reported in the source text, the hazard directly impacts life-sustaining equipment used in emergency settings, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
SunMed Holdings, LLC is recalling RescuMed manual resuscitators with integrated manometer in adult, infant, and pediatric configurations. The affected devices include multiple reference models (BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F for adult; BVMB710 and BVMB710-F for infant; and BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F for pediatric).
A backwards leak in the integrated manometer of the patient valve allows for CO2 rebreathing during ventilation. This defect can compromise the effectiveness of manual ventilation and pose a risk to patient safety during emergency resuscitation.
The recalled devices were distributed nationwide across 32 states including Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, and West Virginia. All lots manufactured from September 21, 2018 to present are affected, with the latest expiration date of October 11, 2028.
Healthcare facilities and individuals who have received these devices should contact SunMed Holdings, LLC immediately regarding the recall. Do not use affected resuscitators if the backwards leak defect is confirmed.
The recalled product
- Product
- 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. RescuMe
- Manufacturer
- SunMed Holdings, LLC
- Hazard
- co2-rebreathing
- respiratory-hazard
- valve-defect
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 (20)
- UDI-DI: 10889483164266
- (ITEM # BVM510-F
- Case UDI: 30889483184680)
- UDI-D: 10889483164754
- (ITEM # BVMB710
- Case UDI: 30889483164758)
- UDI-DI: 10889483164785
- (ITEM # BVMB812
- Case UDI: 30889483164789)
- UDI-DI: 10889483164761
- (ITEM # BVMB812-F
- Case UDI: 30889483164765)
- UDI-DI: 10889483169605
- (ITEM # BVMB510-10
- Case UDI: 30889483169609)
- UDI-DI: 10889483164686
- (ITEM # BVMB510-F
- Case UDI: 0889483164680)
- UDI-DI: 10889483164693
- (ITEM # BVMB510S-F
Distribution
Distributed nationwide across the United States.
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