Recall archive / FDA device enforcement
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Samp... — FDA record Z-2654-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
- Classification
- Class II
- Recalling firm
- BD SWITZERLAND SARL
- Quantity
- 50 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2654-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: IL O.U.S: N/A
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 8, 2026
- Recall initiation date
- Jun 4, 2026
- Center classification date
- Jul 2, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.