Class 2 Device Recall MEDLINE 111 GRAVITY SET W/3 Needle Free YSites

• Date Initiated by Firm: June 04, 2026
• Date Posted: July 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2654-2026
• Recall Event ID: 99085
• Product Classification: Set, administration, intravascular - Product Code FPA
• 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
• Code Information: Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
• FEI Number: 3012798826
• Recalling Firm/ Manufacturer: BD SWITZERLAND SARL; Terre Bonne Park A4; Route De Crassier 17; Eysins Switzerland
• For Additional Information Contact: Fallon McLoughlin; 201-258-0361
• Manufacturer Reason for Recall: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
• FDA Determined 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: productcomplaints@bd.com
• Quantity in Commerce: 50 devices
• Distribution: U.S.: IL O.U.S: N/A
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.