V-Care manual resuscitators recalled for CO2 rebreathing defect
SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were 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 involving a physical defect in a critical-care device that presents a direct risk of patient harm through CO2 rebreathing during resuscitation. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
SunMed Holdings, LLC is recalling Ventlab V-Care manual resuscitators in multiple configurations, including child, infant, pediatric, and small adult models. The recalled devices contain an integrated manometer that may have a backwards leak.
The backwards leak in the patient valve's integrated manometer can allow CO2 rebreathing. This defect may compromise the proper function of the resuscitator during use.
The recalled resuscitators were distributed nationwide across multiple U.S. states. All units manufactured from September 21, 2018 through present with the latest expiration date of October 11, 2028 are affected.
Healthcare facilities and clinicians using these devices should contact SunMed Holdings, LLC immediately for instructions on device return, replacement, or remediation.
The recalled product
- Product
- Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, V
- Manufacturer
- SunMed Holdings, LLC
- Hazard
- co2-rebreathing
- backwards-leak
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)
- ITEM # VN2100MB
- UDI-DI: 10889483095379
- (Case UDI: 30889483095373)
- ITEM # VN2100MBF
- UDI-DI: 10889483092774
- (Case UDI: 30889483092778)
- ITEM # VN2100MBP
- UDI-DI: 10889483108260
- (Case UDI: 30889483108264)
- ITEM # VN2100MB-PW
- UDI-DI: 10889483108253
- (Case UDI: 30889483108257)
- ITEM # VN2100MC
- UDI-DI: 10889483108277
- (Case UDI: 30889483108271)
- ITEM # VN2100MCP
- UDI-DI: 10889483094525
- (Case UDI: 30889483094529)
- ITEM # VN2100MX-M123
- UDI-DI: 10889483098936
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27