LACTATED RINGER'S IRRIGATION, 3000 mL recall — B Braun Medical Inc (Class II)
B Braun Medical Inc is recorded by the U.S. Food and Drug Administration (FDA) as recalling LACTATED RINGER'S IRRIGATION, 3000 mL — a Class II recall, initiated 2026-04-02 and posted to the FDA enforcement report on 2026-04-29, under recall number D-0498-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.”. From the product description, the strength given is 3000 mL and the package is described as 3000 mL bags. 1 National Drug Code number is printed in the record: 0264-7389-60. Distribution is recorded as “US Nationwide” — Nationwide (US), with the recalling firm on record in PA, United States. The FDA files it under event ID 98693 together with 1 other recall number, all listed and linked below. Within that event this is the strength 3000 mL, package 3000 mL bags and ndc 0264-7389-60 configuration; the sibling records differ on strength, package, form and ndc, and 1 more and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0498-2026 |
|---|---|
| FDA event ID | 98693 (2 recall numbers) |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | B Braun Medical Inc |
| Recall initiated | 2026-04-02 |
| Reported by FDA | 2026-04-29 |
| Report lag | 27 days from initiation to report |
| Distribution | US Nationwide. — Nationwide (US) |
| Firm location on record | PA, United States |
| Product description (source) | LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60. |
Reason reported by FDA
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
17 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.
Product identifiers in this record
3 identifying values matched by exact pattern in the 19-word product description above; each is a literal substring of it.
| Product named | LACTATED RINGER'S IRRIGATION |
|---|---|
| Strength | 3000 mL |
| Package | 3000 mL bags |
| NDC | 0264-7389-60 |
Which configuration this record is
2 recall numbers share event 98693. They differ on strength, package, form, ndc and product named and agree on everything else the source states, so those are the values to check a package against.
| Attribute | This record (D-0498-2026) | D-0496-2026 |
|---|---|---|
| Strength | 3000 mL | 70% · 2000 mL |
| Package | 3000 mL bags | 2000 mL bags |
| Form | — | Injection |
| NDC | 0264-7389-60 | 0264-7387-50 |
| Product named | LACTATED RINGER'S IRRIGATION | DEXTROSE INJECTION USP |
Shared across all 2 records under this event: fda tier Class II; recalling firm B Braun Medical Inc; the same reason text; initiated 2026-04-02; reported 2026-04-29.
Event context: 2 recall numbers under event 98693
One enforcement action, 2 recall numbers: the FDA filed 1 further configuration of this action under event 98693. Each keeps its own recall number and dates.
| Recall record | Recall number | FDA tier | Strength / form | NDC | Reported |
|---|---|---|---|---|---|
| DEXTROSE INJECTION USP, 70% | D-0496-2026 | Class II | 70% · Injection | 0264-7387-50 | 2026-04-29 |
Other indexed recalls from B Braun Medical Inc
3 indexed records name B Braun Medical Inc as the recalling firm, across 2 FDA events, reported 2026-04-29 to 2026-05-13. A coverage-limited activity count over the ingested window, not a quality rating.
| Recall record | Recall number | FDA tier | Strength / form | Reported |
|---|---|---|---|---|
| Lactated Ringer's Injection USP, 1000 mL | D-0540-2026 | Class I | 1000 mL · Injection | 2026-05-13 |
Reported in the same month (2026-04)
6 enforcement reports carry a report date in 2026-04; these 3 are the Class II ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| Furosemide Tablets, 80 mg | D-0486-2026 | Leading Pharma, LLC | Class II | 2026-04-29 |
| FRESHKOTE LUBRICANT EYEDROPS, 10mL | D-0489-2026 | Harrow Eye LLC | Class II | 2026-04-29 |
| Omega-3-Acid, 1 gram | D-0493-2026 | The Harvard Drug Group LLC | Class II | 2026-04-29 |
Nearest Class II recalls by date
213 of 250 indexed records share the Class II tier; the 10 nearest to 2026-04-29 by report date are listed here.
| Recall record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| Systane, 10g | D-0491-2026 | Alcon Research LLC | 10g · Gel | 2026-05-06 |
| GenTeal Tears, 10g | D-0492-2026 | Alcon Research LLC | 10g · Gel | 2026-05-06 |
| Optase Dry Eye Intense Drops (Glycerin 0.2%) | D-0499-2026 | Scope Health | 0.2% · Drops | 2026-05-06 |
| iVIZIA, 0.5% | D-0500-2026 | Thea Pharma, Inc. | 0.5% · Eye Drops | 2026-05-06 |
| Similasan, 0.5% | D-0501-2026 | Thea Pharma, Inc. | 0.5% · Eye Drops | 2026-05-06 |
| Phenylephrine Hydrochloride Injectable Solution, 40mg | D-0502-2026 | Wells Pharma OF Houston LLC | 40mg · Solution | 2026-05-06 |
| fentaNYL Citrate Injectable Solution, 1000 mcg/100 mL | D-0503-2026 | Wells Pharma OF Houston LLC | 1000 mcg/100 mL · Solution | 2026-05-06 |
| fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride | D-0504-2026 | Wells Pharma OF Houston LLC | 0.9% · Solution | 2026-05-06 |
| fentaNYL Citrate Injectable Solution, 1250 mcg/25mL | D-0505-2026 | Wells Pharma OF Houston LLC | 1250 mcg/25mL · Solution | 2026-05-06 |
| fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride | D-0506-2026 | Wells Pharma OF Houston LLC | 0.9% · Solution | 2026-05-06 |
Reading this record
Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 98693 returns all 2 of these recall numbers; a search on D-0498-2026 returns only this configuration. Match a package against 0264-7389-60 at the FDA source to confirm it is covered.
Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); B Braun Medical Inc (3 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0498-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0498-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-04-29
- Ingested
- 2026-08-22
- Record hash
49c8fe18eeef9f77
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.