FDAClass II · Drug · Recall D-0497-2026 · Recalled April 29, 2026
0 recall — B BRAUN MEDICAL INC
Agency report date: April 29, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: 0 recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
More B BRAUN MEDICAL recalls
- 0 recall — B BRAUN MEDICAL INCFDA · September 16, 2026
- Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INCFDA · September 2, 2026
- Design Options Spinal Tray Spinal Needle Anesthesia procedure kits recall — B Braun Medical IncFDA · June 10, 2026
- Spinocan Spinal Needle procedure kits recall — B Braun Medical IncFDA · June 10, 2026
- Spinal Needle procedure kits recall — B Braun Medical IncFDA · June 10, 2026
Other drug recalls from around the same time
- BEEKEEPER'S NATURALS Saline Nasal Spray recall — BEEKEEPER'S NATURALS USA INC.FDA · June 17, 2026
- Gas-X Extra Strength recall — Haleon US Holdings LLCFDA · June 17, 2026
- DOXOrubin Hydrochloride Liposome injection recall — SUN PHARMACEUTICAL INDUSTRIES INCFDA · June 17, 2026
- MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%) recall — Wisconsin Pharmacal CompanyFDA · May 27, 2026
- Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INCFDA · May 13, 2026
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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved July 28, 2026 at 11:00 PM UTC.