Food, drugs, devices › B Braun Medical Inc

Device recall: Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025

FDA enforcement event 99550 · Class II · initiated 4 Aug 2026 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordBethlehem, PA

FDA enforcement event 99550 is a device recall by B Braun Medical Inc of Bethlehem, PA, initiated 4 Aug 2026 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device 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, Bethlehem, PA.

Reason for recall

"Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label."

Distribution

"Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX, VA, WA the country of Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-3089-2026	Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025	25850	Class II	Ongoing	9 Sep 2026

Context

87%of 2026 device events are Class II572 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
12 Aug 2026	Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-35	Drug	Class I	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 device recalled?

FDA's record gives the reason for recall as: "Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX, VA, WA the country of Canada."

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 device 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.