# FDA recall Z-0364-2024

> **SunMed Holdings, LLC** · Class II · device recall initiated 2023-10-11.

## 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 for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

## 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.

## Key facts

- **Recall number:** Z-0364-2024
- **Recalling firm:** SunMed Holdings, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-11
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0364-2024

## Citation

> AI Analytics. FDA recall Z-0364-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0364-2024. Source: US FDA. Licensed CC0.

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