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RecallWatchMedical Device Safety
Class IIOngoingZ-2654-2026

BD SWITZERLAND SARL recalls MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM246…

BD SWITZERLAND SARLEysins, SwitzerlandReported Jul 8, 2026 · 10 days ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI codeREF DYNDTN0555Catalog # Number
    Affected lot
    25X445

What the firm is doing

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

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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