Lower risk Medical device recall · FDA · Published June 4, 2026

BD MEDLINE 111 Gravity Set with 3 Needle-Free Y-Sites: Not for Human Use Hazard

BD recalls MEDLINE 111 Gravity Set with 3 Needle-Free Y-Sites (Catalog SAM2461) shipped as engineering sample labeled 'Not for Human Use' in the U.S. market.

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

🇺🇸 FDA recall #Z-2654-2026Medical device BD ›

Lower-risk recall

Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

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 a specific gravity set designed for medical use because it was mistakenly shipped to the U.S. as an engineering sample marked 'Not for Human Use'. This means the product should not be used on patients. Read more at govinfonow.com/recall/49044-bd-medline-111-gravity-set-with-3-needle-free-y.

Source Summary by GovInfoNow · govinfonow.com/recall/49044-bd-medline-111-gravity-set-with-3-needle-free-y · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2654-2026

Cite this page

“BD MEDLINE 111 Gravity Set with 3 Needle-Free Y-Sites: Not for Human Use Hazard.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49044-bd-medline-111-gravity-set-with-3-needle-free-y. Based on FDA recall #Z-2654-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2654-2026%22&limit=1).

BD SWITZERLAND SARL recalled MEDLINE gravity sets with needle-free Y-sites because engineering samples labeled "Not for Human Use" were shipped to the U.S., according to the FDA on June 4, 2026.

How to tell if you have it

Brand: BD
Product: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites
REF: DYNDTN0555
Catalog Number: SAM2461
Lot Number: 25X445

The hazard

The recall involves engineering samples labeled "Not for Human Use" that were inadvertently shipped to the U.S. market.

Context

GovInfoNow's records show BD SWITZERLAND SARL has issued eight other recalls since April 9, 2020. Recent brand recalls include a June 16, 2026 notice for BD 60-In Extension Sets regarding inadequate sterilization and an Aug. 19, 2026 recall of BD Alaris Pump Infusion Sets due to performance data discrepancies. Other recent recalls of similar products include B Braun Medical IV Set Recalls from Oct. 29, 2025 concerning backflow risks in gravity IV systems and pumps.

How to tell if you have this one

Check for the catalog number SAM2461 and reference DYNDTN0555 on the product. This gravity set was shipped to the U.S. market as an engineering sample labeled 'Not for Human Use'.

Brand
BD
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the catalog number SAM2461 and reference DYNDTN0555 on the product.

Where it went and when

Where it was distributed

Distributed in Illinois.

FDA distribution: “U.S.: IL O.U.S: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois.

Recall timeline

FDA published this recall 34 days after the firm started it.

Jun 4, 2026Firm started the recall
Jul 2, 2026FDA classified it Class II
Jul 8, 2026Published 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/49044-bd-medline-111-gravity-set-with-3-needle-free-y">BD MEDLINE 111 Gravity Set with 3 Needle-Free Y-Sites: Not for Human Use Hazard (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-2654-2026 (June 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2654-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.