Lower risk Medical device recall · FDA · Published February 20, 2025

BD Connecta Luer-Lok 360: Outside US Instructions May Cause Errors

BD recalls Connecta Luer-Lok 360 and Plus models with specific lot numbers due to outside US instructions that could lead to IV therapy errors.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1509-2025Medical device BD ›

Lower-risk recall

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

Take action

Contact the company

Recalling firmBD SWITZERLAND SARLTerre Bonne Park A4, Route De Crassier 17 · Eysins, Switzerland

✎ GovInfoNow plain-language explainer

BD is recalling certain Connecta Luer-Lok 360 and Plus models because they were shipped with instructions for use outside the U.S. These instructions may cause errors in IV therapy. Affected users should check their product's lot numbers and contact BD for guidance. Read more at govinfonow.com/recall/52790-bd-connecta-luer-lok-360-outside-us-instructions-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/52790-bd-connecta-luer-lok-360-outside-us-instructions-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1509-2025

Cite this page

“BD Connecta Luer-Lok 360: Outside US Instructions May Cause Errors.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52790-bd-connecta-luer-lok-360-outside-us-instructions-may-cause. Based on FDA recall #Z-1509-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1509-2025%22&limit=1).

BD SWITZERLAND SARL recalled BD Connecta BD Luer-Lok 360 stopcocks because specific lots shipped to the U.S. had an Outside US Instruction for Use, the FDA said on Feb. 20, 2025.

How to tell if you have it

Brand: BD
Product: BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks
Catalog Number: 394910
Lot Numbers: 4277968, 4277973, 4282451, 4282461, 4289801, 4290582, 4292904, 4295848, 4305108, 4306700
Quantity: 500 units

The hazard

The recalled devices were shipped with an Outside US Instruction for Use. The FDA classified the recall as Class II.

Context

GovInfoNow's records show BD SWITZERLAND SARL has issued eight other recalls since April 9, 2020. Recent similar product recalls include Tand pumps with Czech guide errors (Jan. 30, 2026) and American Contract Systems Convenience Kits with catheters that may not meet performance specs (June 29, 2026).

How to tell if you have this one

Check the product's lot numbers: 4277968, 4277973, 4282451, 4282461, 4289801, 4290582, 4292904, 4295848, 4305108, or 4306700. The UDI-DI code is 00382903949106 for these specific models.

Brand
BD
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Identify the lot numbers on your BD Connecta Luer-Lok 360 or Plus model to see if they match the affected lots listed.
Contact BD for Guidance
Reach out to BD directly to confirm if your device is affected and get instructions on next steps.

Where it went and when

Where it was distributed

Distributed in 35 states.

FDA distribution: “U.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN. TX, UT, VA, WA, WV O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 48 days after the firm started it.

Feb 20, 2025Firm started the recall
Apr 2, 2025FDA classified it Class II
Apr 9, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52790-bd-connecta-luer-lok-360-outside-us-instructions-may-cause">BD Connecta Luer-Lok 360: Outside US Instructions May Cause Errors (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1509-2025 (February 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1509-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.