FDA recall, , Moderate risk
B. Braun Sterile Water, Dextrose, Sodium Chloride and Lactated Ringer's Injections and Irrigation
Sterile Water for Injection USP lacks assurance of sterility, which could cause leakage from the diaphragm port.
Summary by Recall Canary from the FDA notice
What happened
B. Braun Medical Inc. of Allentown, Pennsylvania, recalled several sterile products due to a lack of assurance of sterility, with a potential for leakage from the diaphragm port once the foil is removed.
The recall, which began April 2, 2026, and was added to the FDA's Enforcement Report on April 22, 2026, covers Dextrose Injection USP 70% in 2000 mL bags, Lactated Ringer's Irrigation in 3000 mL bags, Sterile Water for Injection USP in 3000 mL bags, and 0.9% Sodium Chloride Irrigation USP in 3000 mL bags. The products were distributed nationwide.
2 photos
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
4 products
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Lactated Ringer's Irrigation, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA
- NDC
- 0264-7389-60
- Lot code
- J5E234
- J5E236
- J5H158
- J5H159
- J5H160
- J5H161
- J5H162
- J5H163
- J5H174
- J5H175
Dextrose Injection USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA
- NDC
- 0264-7387-50
- Lot code
- J5H166
- J5H167
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524
- NDC
- 0264-7385-60
- Lot code
- J5H165
- J5E237
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
- Lot code
- J5E226
- J5E227
- J5E228
- J5E229
- J5E230
- J5E231
- J5E232
- J5E233
- J5E238
- J5E239
- J5E240
- J5E241
- J5E242
- J5E243
- J5E244
- J5E245
- J5E247
- J5E248
- J5H151
- J5H152
- J5H153
- J5H154
- J5H155
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- B Braun Medical IncAllentown, Pennsylvania
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking 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
- 98693
- Recall numbers
- D-0495-2026 to D-0498-2026
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
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
Summary updated
