Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1532-2025 — IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for u

U.S. FDA — Device Enforcement · United States · 2025-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1532-2025
Date of alert: 2025-02-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Omnicell, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 298921215

Reported risk: IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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