Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-3085-2024)

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:

Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

Product Classification:

Class I

Date Initiated: August 20, 2024

Date Posted: September 25, 2024

Recall Number: Z-3085-2024

Event ID: 95192

Reason for Recall:

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

Status: Ongoing

Product Quantity: 2,140,046 units

Code Information:

UDI/DI 00085412475813, Lot Numbers: 803807 and lower

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated