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Medline Gravity Set
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MEDICAL DEVICE RECALLMODERATE

Medline Gravity Set

Medline is recalling gravity sets labeled "Not for Human Use" that were inadvertently shipped to the U.S. market.

What to do

Immediately stop using the affected gravity sets and contact the facility or supplier to arrange for return or disposal.

Recalled
Listed
Updated
Recall No.
Z-2654-2026
Agency
FDA
Firm
BD SWITZERLAND SARL
Recall ID
99085
Status
ONGOING

Recall at a glance

Quantity recalled
50 devices

Why it was recalled

Medline is recalling gravity sets with three needle-free Y-sites because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market. These units are not intended for clinical application.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
25X445

Where it was sold

Distributed in Illinois.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-07-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification