FDA · Class I · October 7, 2026

Draeger recall: VentStar Resus Neo

Draeger, Inc. is recalling VentStar Resus Neo – 1,063,643 units. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on September 3, 2026. Distributed nationwide.

Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductVentStar Resus Neo
BrandDraeger
CompanyDraeger, Inc.
TypeMedical devices
ClassificationClass I
Recall dateSeptember 3, 2026
Published by FDAOctober 7, 2026
Quantity1,063,643 units
Recall ID99787
As listed by FDA

Recalled products

  1. VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
    FDA recall number
    Z-3252-2026
    Codes, lots and dates
    Part Number MP00310. UDIDI: 04048675422358. All lot numbers.
    Quantity
    1,063,643 units
    Classification
    Class I
Exactly as the agency lists them

Identifiers and details

FDA event ID
99787
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Telford, PA, United States

Why it was recalled

The reason the FDA lists: “Potential cracks in the hose, which could lead to leakage or the hose falling off.”

Where it was sold

Nationwide. Distribution as the FDA records it: “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, Hong Kong, Malaysia, Costa Rica, Andorra, Belgium, Sweden, Cyprus, Greece, Latvia, Romania, Albania, Moldavia, Kazakhstan, Croatia, Libya, Mauritius, Honduras, Suriname, Uruguay, Syria, Israel, Kuwait, Bahrain, Qatar, Utd.Arab.Emir., Oman, Denmark, Norway, New Zealand, Brunei Darussalam, Singapore, China, India, Japan.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99787, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Our news story: Draeger recalls VentStar Resus Neo

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FAQ

About this recall

Is Draeger VentStar Resus Neo recalled?

Yes. Draeger, Inc. recalled it on September 3, 2026; FDA published it October 7, 2026 (Class I). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Potential cracks in the hose, which could lead to leakage or the hose falling off.

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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