B Braun Medical Inc: FDA regulatory profile
B Braun Medical Inc appears in 3 indexed U.S. FDA records: 3 recall records, naming 3 distinct products. Latest dated event: a recall record dated 2026-05-13. Observations run 2026-04-29 to 2026-05-13 — 14 days, 3 dated records across 1 calendar year, busiest 2026 with 3. Recalls: 1 Class I (33%) and 2 Class II (67%); 3 ongoing by lifecycle status, reported 2026-04-29 to 2026-05-13; 3 with an FDA recall number, 3 with an initiation date, across 1 state, grouped into 2 FDA recall events. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. Recall records: Lactated Ringer's Injection USP (D-0540-2026, Class I, 2026-05-13), DEXTROSE INJECTION USP (D-0496-2026, Class II, 2026-04-29) and LACTATED RINGER'S IRRIGATION (D-0498-2026, Class II, 2026-04-29). Recalling-firm addresses are recorded in PA. Its recall lines are grouped by the FDA into 2 event identifiers: 98693 and 98795.
Regulatory snapshot
| Indexed records | 3 |
|---|---|
| Recall records | 3 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 3 |
| Recall classifications | Class I: 1 · Class II: 2 |
| Recall statuses | Ongoing: 3 |
| First observed | 2026-04-29 |
| Latest observed | 2026-05-13 |
| Latest event type | recall |
| Dated observations | 3 |
| Years covered | 1 |
| Span (days) | 14 |
| Busiest year | 2026 (3 records) |
| Recall states | 1 |
| With recall number | 3 of 3 |
| FDA recall events | 2 |
| Related firms / shortages | 0 / 0 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Recall classification | Class I | 1 | 33% |
| Recall classification | Class II | 2 | 67% |
| Recall status | Ongoing | 3 | 100% |
Recall history (3)
Every enforcement report attributed to this firm, newest first. Classification is the FDA's severity tier, status its lifecycle position — neither is a safety statement.
| Product (as published) | Recall number | Classification | Status | Reported | Initiated |
|---|---|---|---|---|---|
| Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethl | D-0540-2026 | Class I | Ongoing | 2026-05-13 | 2026-04-28 |
| DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethle | D-0496-2026 | Class II | Ongoing | 2026-04-29 | 2026-04-02 |
| LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethl | D-0498-2026 | Class II | Ongoing | 2026-04-29 | 2026-04-02 |
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 98693 | 2 | Class II | 2026-04-29 | 2026-04-29 |
| 98795 | 1 | Class I | 2026-05-13 | 2026-05-13 |
Browse the wider classification index: Class I recalls · Class II recalls.
Products and drugs named (3)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun | recall | 1 | 2026-04-29 |
| Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun | recall | 1 | 2026-05-13 |
| LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun | recall | 1 | 2026-04-29 |
Source limitations
Built from the 3 ingested FDA records for this firm (3 recall, 0 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.