Baxter Seprafilm Adhesion Barrier 1 Half Sheet — Class II medical device recall Z-1689-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-05-01, distributed nationwide. Product was distributed in the United States without proper regulatory approval.
| Recall number | Z-1689-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-03-15 |
| Classified | 2024-04-25 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 165 units |
| UPC / GTIN / UDI-DI | 05413765588310 |
| Lot numbers | DBYSEP046 |
| Model numbers | 664103 |
Product
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Reason for recall
Product was distributed in the United States without proper regulatory approval.
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-1689-2024. 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.