CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report

B Braun Safsite Injection Site, RV1000NC Safsite Valve W/O Extra Cap recalled

B Braun Medical is recalling B Braun Safsite Injection Site, RV1000NC Safsite Valve W/O Extra Cap, distributed nationwide in the US. The recall was initiated on 14 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).

Quantity recalled461,300 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0193-2027
FDA event ID: 99879
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Sep 2026
FDA classified: 16 Oct 2026
Reported: 28 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

14 Sep 2026	Recall initiated by company
16 Oct 2026	Classified by FDA	+32 days
28 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for leakage and backflow at the Safsite valve.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide California Florida Illinois Indiana Minnesota New Jersey New York Ohio Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

Potential for leakage and backflow at the Safsite valve.

Which lots are affected?

Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).

Where was it 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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from B Braun Medical

All 448

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS II	Sesk Upmc Double Catheter Tray recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,950

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: C-section Pack recalled	Medline Industries	Other	Nationwide