CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled

BD Switzerland Sarl is recalling Medline 111 Gravity Set W/3 Needle Free Y-Sites, distributed in Illinois. The recall was initiated on 4 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445

Quantity recalled50 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2654-2026
FDA event ID: 99085
Recalling firm: BD Switzerland Sarl, Eysins, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 4 Jun 2026
FDA classified: 2 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

4 Jun 2026	Recall initiated by company
2 Jul 2026	Classified by FDA	+28 days
8 Jul 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use

Where it was distributed

U.S.: IL O.U.S: N/A

Illinois

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445

Where was it sold?

U.S.: IL O.U.S: N/A

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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