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Open, Classified

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

FDA Recall Z-2654-2026 · Posted 2026-07-02

Recalling FirmBD SWITZERLAND SARL
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2026-06-04
Product Quantity50 devices

Reason for Recall

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

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]

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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