FDA recall, , Moderate risk
B Braun SAFSITE Injection Site
The B Braun Safsite Injection Site has a potential for leakage and backflow.
Summary by Recall Canary from the FDA notice
What happened
B Braun Medical Inc. recalled the B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP, due to a potential for leakage and backflow at the Safsite valve. The company began the recall on September 14, 2026, and it was added to the FDA's Enforcement Report on October 16, 2026.
The recall involves 461,300 units distributed in the U.S. in states including California, Florida, Illinois, Indiana, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington, as well as in Australia, Germany, Malaysia and New Zealand.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and catalog code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
B Braun SAFSITE Injection Site, RV1000NC SAFSITE Valve W/O Extra Cap.
- UDI-DI
- 04022495769862
- 4045928016067
- Catalog code
- 415068.
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Florida, Illinois, Indiana, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and the countries of Australia, Germany Malaysia, New Zealand.
- Company
- B Braun Medical Inc
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99879
- Recall number
- Z-0193-2027
- Quantity recalled
- 461,300 units
All recalls from B Braun Medical Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
