Official recall record
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-12-28
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 26971564466206
- Brand on record
- Cardinal Health 200, LLC
- Product category
- Medical Device
What the authority reported
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-19 · US FDA — Medical Devices
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 - 2026-08-18 · US FDA — Medical Devices
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catal - 2026-08-18 · US FDA — Medical Devices
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catal
All 31 official recall notices naming Cardinal Health 200, LLC on this site →
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