Cardinal Health 200, LLC: Medical Device Recall in 2024 - (Recall #: Z-0849-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

Product Classification:

Class I

Date Initiated: December 28, 2023

Date Posted: February 14, 2024

Recall Number: Z-0849-2024

Event ID: 93676

Reason for Recall:

The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

Status: Ongoing

Product Quantity: 223056 units

Code Information:

UDI/DI 26971564466244 (Case), 16971564466247 (Box),06971564466240 (Each), Lot Numbers: 230501, 230601 and 230602

Distribution Pattern:

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

Voluntary or Mandated:

Voluntary: Firm initiated