Class I — Draeger, Inc.
| Recalling firm | Draeger, Inc. |
|---|---|
| Registered facility | DRAEGER, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Potential cracks in the hose, which could lead to leakage or the hose falling off. |
| Product | VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module. |
| Quantity | 1,063,643 units |
| Distribution | US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, WV, WY, MS, SC, UT, VA, AR, and territories AS and PR. The countries of Canada, Germany, United Kingdom, Spain, Italy, Ireland, Poland, Australia, Switzerland, Netherlands, Portugal, France, Austria… |
| Initiated | 2026-09-03 |
| Classified | 2026-09-30 |
| Recall number | Z-3252-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-14. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Draeger, Inc. (Z-3252-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-14. https://regwarden.com/recall/99787/
Alerts for Draeger, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.