# FDA recall Z-2654-2026

> **BD SWITZERLAND SARL** · Class II · device recall initiated 2026-06-04.

## 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.

## Distribution

U.S.: IL  O.U.S: N/A

## Key facts

- **Recall number:** Z-2654-2026
- **Recalling firm:** BD SWITZERLAND SARL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-04
- **Report date:** 2026-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eysins, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2654-2026

## Citation

> MORVS. FDA recall Z-2654-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2654-2026. Source: US FDA. Licensed CC0.

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