Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0658-2024)

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 Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G

Product Classification:

Class II

Date Initiated: December 6, 2023

Date Posted: January 17, 2024

Recall Number: Z-0658-2024

Event ID: 93503

Reason for Recall:

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Status: Ongoing

Product Quantity:

Code Information:

All serial numbers, no UDI/DI

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated