MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555… — Class II medical device recall Z-2654-2026
Ongoing recall by BD SWITZERLAND SARL, reported 2026-07-08, distributed in IL. Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
| Recall number | Z-2654-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD SWITZERLAND SARL, Eysins, N/A, Switzerland |
| Recall initiated | 2026-06-04 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | IL |
| Quantity | 50 devices |
| Reason classes | labeling |
| Lot numbers | 25X445 |
| Model numbers | DYNDTN0555, SAM2461 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2654-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.