B Braun Medical Inc recalls B Braun SAFSITE Injection Site
- Recalling company
- B Braun Medical Inc
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 14, 2026
- Reported
- Oct 28, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 461,300 units
- Lot / codes
- Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).
- Company location
- Bethlehem, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0193-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0193-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.