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Class IIOngoing

B Braun Medical Inc recalls B Braun SAFSITE Injection Site

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
B Braun Medical Inc
Reason
Potential for leakage and backflow at the Safsite valve.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99879…

Products

  1. B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.

    Codes/lots: Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).Quantity: 461,300 unitsRecall no. Z-0193-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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