FDAFDA recall Z-2654-2026 · Jul 8, 2026
BD SWITZERLAND SARL: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI recall
Recall found
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
Reason for recall
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
- Quantity
- 50 devices
- Distribution
- U.S.: IL O.U.S: N/A
- Recalling firm
- BD SWITZERLAND SARL, Eysins, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-04
Source: openFDA enforcement record Z-2654-2026 · search recall number Z-2654-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.