FDA Medical devices recall ·
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites recall
- Recall number
- Z-2654-2026
- Date
- (initiated June 4, 2026)
- Company / brand
- Bd Switzerland Sarl
Terre Bonne Park A4, Eysins, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
Distribution
U.S.: IL O.U.S: N/A
States: Illinois
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2654-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.