Baxter Ostene Hemostasis Material — Class II medical device recall Z-0658-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-01-17, distributed nationwide. Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below
| Recall number | Z-0658-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-12-06 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
Product
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0658-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.