MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number:... recall (BD SWITZERLAND SARL)
Medical deviceClass IIOngoing
Summary: BD SWITZERLAND SARL is recalling 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. Reason: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
What is being recalled
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
Why
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S.: IL O.U.S: N/A (states named: Illinois)
How to tell if yours is affected
Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2654-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 4, 2026 |
| Reported | July 8, 2026 |
| Company | BD SWITZERLAND SARL |
| Company location | Eysins, N/A, Switzerland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 50 devices |
More recalls from BD SWITZERLAND SARL · all medical device recalls · recalls from June 2026