FDA Classifies Draeger VentStar Resus Neo Recall as Class I
FDA has classified the recall of Draeger VentStar Resus Neo disposable breathing circuits as Class I after cracks were found in the hose, creating a risk of leakage or disconnection that may restrict ventilation or delay therapy in infants.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Draeger is recalling VentStar Resus Neo MP00310 breathing circuits, all lot numbers, because hose cracks can cause leakage or detachment. FDA confirms Class I classification; the database lists the cause as under investigation by the firm.
MedTech Current analysis
Why it matters
A leaking or detached hose can restrict ventilation or delay therapy for infants weighing up to 22 pounds, potentially causing desaturation, hypoxia or death. As of September 3, Draeger had reported no serious injuries or deaths associated with the issue.
Official recall information
Official actions
According to FDA and Draeger's September 3 customer communication:
- Carefully inspect each hose for damage before use in accordance with the product Instructions for Use.
- Discard products with cracks or a detached hose; damaged products do not need to be returned to Draeger.
- Inform all potential users within the facility.
- Notify customers if affected products were transferred or distributed.
- Complete and return the Medical Device Recall Return Response Acknowledgement and Receipt Form.
- Draeger will replace affected circuits free of charge after a correction is implemented, based on the quantity indicated on the response form.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Draeger is removing affected VentStar Resus Neo disposable breathing circuits after users identified obvious cracks in the hose before use. The affected circuit, model MP00310, is designed to convey breathing gas from a source to an infant weighing up to 22 pounds. FDA updated its public communication on October 2, 2026, to confirm the Class I classification.
According to the FDA communication, a cracked hose may leak or detach during use. A leak or disconnection can restrict ventilation or delay therapy, potentially causing desaturation, hypoxia, or patient death during neonatal resuscitation or other critical care. FDA first issued an Early Alert on September 3 and later updated the communication after formal Class I classification.
As of September 3, Draeger had reported no serious injuries and no deaths associated with the issue. The affected product is a single-use neonatal breathing circuit packaged 25 units per box.
Who and what are affected
The recall covers all lot numbers of the VentStar Resus Neo disposable breathing circuit:
| Product | Model | UDI-DI | FDA recall number |
|---|---|---|---|
| VentStar Resus Neo | MP00310 | 04048675422358 | Z-3252-2026 |
The FDA recall database identifies Draeger, Inc. as the recalling firm under Recall Event ID 99787. FDA lists 1,063,643 units in commerce with U.S. nationwide and international distribution.
The FDA database lists the cause as under investigation by the firm. It states that Draeger has not tested and approved alternative products from other manufacturers for use with these devices and has no substitute products within its U.S. portfolio.
What affected organizations should do
Affected customers and facilities
According to Draeger’s September 3 customer communication:
- Carefully inspect each hose for damage before use in accordance with the product Instructions for Use.
- Discard any product that shows cracks.
- Discard any product with a detached hose.
- Damaged products do not need to be returned to Draeger.
- Inform all potential users within the facility about the recall.
- Notify downstream customers if affected products were transferred or distributed.
- Complete and return the Medical Device Recall Return Response Acknowledgement and Receipt Form.
- Draeger will replace affected circuits free of charge after the correction is implemented, based on the quantity indicated on the response form.