B Braun SAFSITE Injection Site recall (B Braun Medical Inc)
Medical deviceClass IIOngoing
Summary: B Braun Medical Inc is recalling B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.. Reason: Potential for leakage and backflow at the Safsite valve.
What is being recalled
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Why
Potential for leakage and backflow at the Safsite valve.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: California, Florida, Illinois, Indiana, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington)
How to tell if yours is affected
Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0193-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 14, 2026 |
| Reported | October 28, 2026 |
| Company | B Braun Medical Inc |
| Company location | Bethlehem, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 461,300 units |
More recalls from B Braun Medical Inc · all medical device recalls · recalls from September 2026