Recall archive / FDA device enforcement
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1... — FDA record Z-0364-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 11, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.
- Reason
- A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Classification
- Class II
- Recalling firm
- SunMed Holdings, LLC
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0364-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, Case UDI: 3088948316469); UDI-DI: 10889483164747, (ITEM # BVMB710-F, Case UDI: 30889483164741); UDI-DI: 10889483164730, (ITEM # BVMB810, Case UDI: 30889483164734); UDI-DI: 10889483164716, (ITEM # BVMB810-F, Case UDI: 30889483164710); UDI-DI: 10889483164723, (ITEM # BVMB810S-F, Case UDI: 30889483164727). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 29, 2023
- Recall initiation date
- Oct 11, 2023
- Center classification date
- Nov 21, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.