Horizon manual resuscitators recalled for CO2 rebreathing hazard
SunMed Holdings is recalling Ventlab Horizon manual resuscitators due to a backwards leak in the integrated manometer that allows carbon dioxide rebreathing. The affected devices were manufactured from September 2018 to the present and distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II medical device recall involves a serious potential hazard—a backwards leak in the integrated manometer enabling carbon dioxide rebreathing—but no illnesses, injuries, or adverse events have been reported. Per the severity rubric, risk-of-harm products without reported injury are rated High (3).
Plain-English summary
Ventlab, LLC Horizon manual resuscitators with integrated manometers are being recalled by manufacturer SunMed Holdings, LLC. The recall covers adult, infant, and pediatric models with multiple reference numbers for each size category. The devices were manufactured from September 21, 2018 to the present.
A backwards leak in the integrated manometer's patient valve allows for carbon dioxide rebreathing. This defect is present in all units manufactured during the affected period.
The recalled resuscitators were distributed nationwide across the United States to 28 states. This is a Class II recall issued by the U.S. Food and Drug Administration under recall number Z-0363-2024.
Healthcare facilities, emergency services, and other users of these devices should contact SunMed Holdings, LLC for further information and guidance regarding the recalled resuscitators.
The recalled product
- Product
- Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant…
- Manufacturer
- SunMed Holdings, LLC
- Category
- Medical Device — Resuscitators
- Hazard
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: 10889483166611 (Item # 6009HZ
- Case UDI: 30889483166615) UDI-DI: 10889483167786 (Item#: 6013HZ
- Case UDI: 30889483167780) UDI-DI: 10889483170786 (Item#: 6019HZ
- Case UDI: 30889483170780) UDI-DI: 10889483166437 (Item#: 6106HZ
- Case UDI: 30889483166431) UDI-DI: 10889483166444 (Item#: 6107HZ
- Case UDI: 30889483166448) UDI-DI: 10889483166499 (Item#: 6112HZ
- Case UDI: 30889483166493) UDI-DI: 10889483167779 (Item#:6116HZ
- Case UDI: 30889483167773) UDI-DI: 10889483167885 (Item#: 6117HZ
- Case UDI: 30889483167889) UDI-DI: 10889483168233 (Item # 6118HZ
- Case UDI: 30889483168237) UDI-DI: 10889483170199 (Item # 6123HZ
- Case UDI: 30889483170193) UDI-DI: 10889483171189 (Item # 6125HZ
- Case UDI: 30889483171183) UDI-DI: 10889483170984 (Item # 6200HZ
- Case UDI: 30889483170988) UDI-DI: 10889483166680 (Item # 8003HZ
- Case UDI: 30889483166684) UDI-DI: 10889483166697 (Item # 8004HZ
- Case UDI: 30889483166691) UDI-DI: 10889483230831(Item # 8010HZ
- Case UDI: 30889483230834) UDI-DI: 10889483172650 (Item # 8105HZ
- Case UDI: 30889483172654) UDI-DI: 10889483166741(Item # 8106HZ
- Case UDI: 30889483166745) UDI-DI: 10889483166758 (Item # 8107HZ
- Case UDI: 30889483166752) UDI-DI: 10889483166772 (Item # 8109HZ
- Case UDI: 30889483166776) UDI-DI: 10889483166819 (Item # 8113HZ
Distribution
Part of a larger recall action
This product is one of 9 recalled by SunMed Holdings, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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