Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026

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

Bd Switzerland Sarl

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BD SWITZERLAND SARL · Terre Bonne Park A4, Route De Crassier 17 · Eysins

Is this the product you have?

  • MEDLINE 111 GRAVITY SET W/3 Needle Free
  • Y-Sites REF DYNDTN0555 Catalog NumberSAM2461
  • UDI codeN/A Engineering Sample/Not for Human Use
Lot codes and dates
  • Catalog NumberSAM2461
  • REFDYNDTN0555
  • UDI codeN/A
  • Lot Number25X445
Amount recalled
50 devices

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 6:32 PM UTC

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