Z-2654-2026Class II

MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A...

Name: Z-2654-2026 MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A...
Creator: Bd Switzerland Sarl
Published: 2026-06-04
License: https://open.fda.gov/license/

BD Switzerland SARL / initiated 2026-06-04 / Open, Classified / root cause: labeling and UDI

FDA source

BD SWITZERLAND SARL began a recall of 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 on 2026-06-04. FDA classified it as Class II and gives the reason as "Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2654-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-04
Posted: 2026-07-02
Recalling firm: BD Switzerland SARL
Product: 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
Product code: FPA Set, Administration, Intravascular
Reason for recall: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 06/04/2026, the firm email an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customers that BD is recalling Engineering Samples labelled Not for Human Use listed above that were inadvertently shipped to the U.S. market. Customers are instructed to: 1. Cease use and destroy any unused affected product listed in the table above according to your facilities regulations. 2. Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. For Questions - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: [email protected]
Quantity in commerce: 50 devices
Distribution: U.S.: IL O.U.S: N/A
Product codes and lots: Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2654-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2654-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)