Ventlab Infant Resuscitator Recalled for Possible Volume Leakage
Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.
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: The recall involves a high-risk medical device intended for life-saving resuscitation where a functional defect (leakage) poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the Breath Tech Safe Spot Infant Resuscitator, BT2000 Series. These single-use medical devices are intended to provide respiratory support for infants experiencing reversible apnea, such as during cardiopulmonary arrest. The recall covers specific product codes and lot numbers, including BT2200FK, BT2216, and BT2420FK.
The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could compromise the device's ability to deliver the intended respiratory support. The affected units were distributed nationwide, with specific mentions of Illinois, Ohio, New York, and Tennessee.
Healthcare facilities and consumers who possess these specific lot numbers should stop using the devices immediately. Ventlab Corporation is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of
- Manufacturer
- Ventlab Corporation
- Hazard
- Affected units
- 14,602
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)
- Code: Product List 071012
- Product Codes: BT2200FK
- Lot #100196
- BT2216
- Lot #100138
- BT2216F
- Lot #100139
- BT2216K
- Lot #100197
- BT2220
- Lot #100140
- Lot #100141
- BT2416
- Lot #100142
- BT2416F
- Lot #100143
- BT2416K
- Lot #100198
- BT2420
- Lot #100144
Distribution
Part of a larger recall action
This product is one of 12 recalled by Ventlab Corporation 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.
See all 12 products in this recall →Related recalls
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See all →- ModerateVentlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
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- SevereVentlab Infant Resuscitator Recalled for Possible Volume Leakage
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- HighVentlab Premium Small Adult Resuscitator Recalled for Valve Leakage
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- SevereVentlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
FDA (Devices) · 2012-11-07
- HighVentlab AirFlow Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
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