Food, drugs, devices › B BRAUN MEDICAL INC

Drug recall: Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-35

FDA enforcement event 99633 · Class I · initiated 12 Aug 2026 · status Ongoing

DrugVoluntary: Firm initiated1 product recordAllentown, PA

FDA enforcement event 99633 is a drug recall by B BRAUN MEDICAL INC of Allentown, PA, initiated 12 Aug 2026 and classified Class I, with 1 product record.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 11% of the 234 drug enforcement events initiated in 2026 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. B BRAUN MEDICAL INC has 90 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

B BRAUN MEDICAL INC, Allentown, PA.

Reason for recall

"Presence of Particulate matter."

Distribution

"U.S. Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0832-2026	Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00	23,688 bags	Class I	Ongoing	2 Sep 2026

Context

11%of 2026 drug events are Class I234 events that year

1product record in this eventfirm median: 1

90events on this register for the firm

Other enforcement events for B BRAUN MEDICAL INC

Initiated	Product (first record)	Type	Class	Records
19 Aug 2026	0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc	Drug	Class I	1
4 Aug 2026	Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025	Device	Class II	1
6 May 2026	Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867);	Device	Class I	3
28 Apr 2026	Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0	Drug	Class I	1
2 Apr 2026	Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801	Drug	Class II	4
19 Mar 2026	B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.	Device	Class I	6
2 Feb 2026	Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N	Device	Class II	3
29 Jan 2026	Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Vers	Device	Class II	8
29 Oct 2025	ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar	Device	Class II	116
30 Sep 2025	Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096	Device	Class I	1

All 90 events for B BRAUN MEDICAL INC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Presence of Particulate matter."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "U.S. Nationwide"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.