CLASS II ONGOING Drug recall · Reported 29 Apr 2026 · FDA Enforcement Report

0.9 % Sodium Chloride Irrigation recalled by B Braun Medical

B Braun Medical is recalling 0.9 % Sodium Chloride Irrigation, USP, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.

NDC0264-7388

Quantity recalled124,244 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0497-2026
FDA event ID: 98693
Recalling firm: B Braun Medical, Allentown, PA
Brand: Sodium Chloride For Irrigation
Manufacturer: B. Braun Medical Inc.
Classification: Class II
Status: Ongoing
Recall initiated: 2 Apr 2026
FDA classified: 28 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

2 Apr 2026	Recall initiated by company
28 Apr 2026	Classified by FDA	+26 days
29 Apr 2026	Published in enforcement report	+1 day

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

Reason for recall

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Which lots are affected?

Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.

Where was it sold?

US Nationwide.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 98693

This product is part of a recall event; the main page for the event is Dextrose Injection recalled by B Braun Medical.

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026	CLASS II	Dextrose Injection recalled by B Braun MedicalDextrose	B Braun Medical	Sterility	Nationwide
29 Apr 2026	CLASS II	Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation	B Braun Medical	Sterility	Nationwide
29 Apr 2026	CLASS II	Sterile Water for Injection recalled by B Braun MedicalSterile Water	B Braun Medical	Sterility	Nationwide

More recalls from B Braun Medical

All 447

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 Sodium Chloride For Irrigation recalls

All 2

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	0.9% Sodium Chloride Irrigation recalled by B Braun MedicalSodium Chloride For Irrigation	B Braun Medical	Sterility	Nationwide